Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments (POSITIVE)

May 30, 2011 updated by: Positive Trial Group

Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension

The study is being conducted to compare the effect of standard treatment (target LDL-C level: <120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: <70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Aomori city, Japan
    - Fukushi Clinic
  - Ayase city, Japan
    - Kashiwagi Clinic
  - Chigasaki city, Japan
    - Hayashi Diabetes Clinic
  - Joetsu city, Japan
    - Uchiyama Clinic
  - Kamiinagun, Japan
    - Nitta Medical Clinic
  - Kawasaki city, Japan
    - Imai Clinic
  - Kitakyusyu City, Japan
    - Tani Clinic
  - Koganei city, Japan
    - Marumo Clinic
  - Kyoto city, Japan
    - Ihara Clinic
  - Matsudo city, Japan
    - Goko-Hospital
  - Moka city, Japan
    - Satou Clinic
  - Nirasaki city, Japan
    - Iino Clinic
  - Osaka City, Japan
    - Miura Clinic
  - Otsuki City, Japan
    - Kuroda Iin
  - Sendai city, Japan
    - Sasaki Clinic
  - Shiki city, Japan
    - Kamata Clinic of Internal Medicine
  - Shimoda city, Japan
    - Nishikawa Clinic
  - Shimoinagun, Japan
    - Satou Iin
  - Shinshiro city, Japan
    - Kumagai Clinic
  - Toyokawa city, Japan
    - Suzuki Clinic
  - Yamagata city, Japan
    - Benibana Clinic
  - Yokohama city, Japan
    - Fujimi Clinic
  - Yokohama city, Japan
    - Hongo Clinic
  - Yokohama city, Japan
    - Jiyukai Yamada Naika
  - Yokohama city, Japan
    - Shonan Ochanomizu Clinic
  - Yokohama city, Japan
    - Tani Clinic Internal Medicine, Allergology & Rheumatology
- Aichi pref.
  - Nagoya city, Aichi pref., Japan
    - Hiramitsu Heart Clinic
  - Nagoya city, Aichi pref., Japan
    - Medical Dock&Clinic
- Ehime pref.
  - Iyo gun, Ehime pref., Japan
    - Matsuno Medical Clinic
  - Matsuyama city, Ehime pref., Japan
    - Ishite Matsumoto Naika Junkanki Clinic
  - Niihama city, Ehime pref., Japan
    - Ehime Medical CO-OP Izumigawa Clinic
- Fukui pref.
  - Echizen city, Fukui pref., Japan
    - Tsugawa Internal Medicine Clinic
  - Fukui city, Fukui pref., Japan
    - Fukui Chuo Clinic
  - Sakai city, Fukui pref., Japan
    - Koshino Clinic
- Fukuoka pref.
  - Chikushino city, Fukuoka pref., Japan
    - Fukuoka University Chikushi Hospital
  - Chikushino city, Fukuoka pref., Japan
    - Saiseikai Futsukaichi Hospital
  - Fukuoka city, Fukuoka pref., Japan
    - Abies Clinic
  - Fukuoka city, Fukuoka pref., Japan
    - Hirano Medical Clinic
  - Fukuoka city, Fukuoka pref., Japan
    - Naitoh Clinic
  - Fukuoka city, Fukuoka pref., Japan
    - Saku Hospital
  - Kasuga city, Fukuoka pref., Japan
    - Fukuoka Tokushukai Medical Center
  - Kitakyusyu city, Fukuoka pref., Japan
    - Morizono Naika
- Gifu pref.
  - Gifu city, Gifu pref., Japan
    - Kawai Naika Clinic
- Hiroshima pref.
  - Hiroshima city, Hiroshima pref., Japan
    - Hiroshima General Hospital of West Japan Railway Company
- Hokkaido pref.
  - Date city, Hokkaido pref., Japan
    - Hijirigaoka Hospital
  - Hakodate city, Hokkaido pref., Japan
    - Kyoaikai Hospital
  - Kato-gun, Hokkaido pref., Japan
    - Miyazawa Cardiovascular And Internal Medicine Clinic
  - Obihiro city, Hokkaido pref., Japan
    - Jiyugaoka Yamada Clinic
  - Sapporo city, Hokkaido pref., Japan
    - Chikama Clinic
  - Sapporo city, Hokkaido pref., Japan
    - Hiro Clinic
  - Sapporo city, Hokkaido pref., Japan
    - Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital
  - Sapporo city, Hokkaido pref., Japan
    - Seiwa Memorial Hospital
  - Yubari city, Hokkaido pref., Japan
    - Medical Treatment Corporate Foundation Yubari Kibounomori Yubari City Clinic
- Hyogo pref
  - Amagasaki city, Hyogo pref, Japan
    - Katsuya Clinic
  - Kobe city, Hyogo pref, Japan
    - Kotani Diabetes Clinic
  - Kobe city, Hyogo pref, Japan
    - Shimizu Clinic
  - Nishinomiya city, Hyogo pref, Japan
    - Dr. Kodama's Office of Internal Medicine
- Hyogo pref.
  - Himeji city, Hyogo pref., Japan
    - Ino Hospital
- Ibaraki pref.
  - Koga city, Ibaraki pref., Japan
    - Koga Hospital
- Ishikawa pref.
  - Hakusan city, Ishikawa pref., Japan
    - Imura Internal Medicine Clinic
  - Hakusan city, Ishikawa pref., Japan
    - Yanagi Medical Clinic
  - Ishikawa gun, Ishikawa pref., Japan
    - Okyozuka Clinic
  - Kahoku gun, Ishikawa pref., Japan
    - Koni Clinic
  - Kahoku gun, Ishikawa pref., Japan
    - Murata Clinic
  - Kanazawa city, Ishikawa pref., Japan
    - Arai Naika Clinic
  - Kanazawa city, Ishikawa pref., Japan
    - Dr. Hayakawa's Family Clinic
  - Kanazawa city, Ishikawa pref., Japan
    - Wakasa Medical Clinic
  - Komatsu city, Ishikawa pref., Japan
    - Morita Hospital
- Iwate pref.
  - Ichinoseki, Iwate pref., Japan
    - Kawasaki Family Clinic
  - Iwate gun, Iwate pref., Japan
    - Sugie Clinic
  - Morioka city, Iwate pref., Japan
    - Katsura General Clinic
  - Shiwa gun, Iwate pref., Japan
    - Takamiya General Clinic
- Kagawa pref.
  - Marugame city, Kagawa pref., Japan
    - Hayashi Clinic
  - Marugame city, Kagawa pref., Japan
    - Otsuka Internal Medicine Clinic
  - Takamatsu city, Kagawa pref., Japan
    - Center for Preventive Medical Treatment, NTT West Takamatsu Hospital
  - Takamatsu city, Kagawa pref., Japan
    - Hananomiya Clinic
  - Takamatsu city, Kagawa pref., Japan
    - Hasegawa Outpatients Clinic for Cardiovascular Disease
  - Takamatsu city, Kagawa pref., Japan
    - Kojima Clinic
  - Takamatsu city, Kagawa pref., Japan
    - Matsuoka Clinic
- Kagoshima pref.
  - Kanoya city, Kagoshima pref., Japan
    - Osumi-Kanoya Hospital
  - Kumage gun, Kagoshima pref., Japan
    - Yakushima Tokushukai Hospital
- Kanagawa pref.
  - Ashigara-kami gun, Kanagawa pref., Japan
    - Nemoto G.I.M. Clinic
  - Ashigarakami gun, Kanagawa pref., Japan
    - Magokoro Internal Medicine and Orthopedic Clinic
  - Atsugi City, Kanagawa pref., Japan
    - Kasuya Clinic
  - Fujisawa city, Kanagawa pref., Japan
    - Kuboshima Clinic
  - Fujisawa city, Kanagawa pref., Japan
    - Takahashi Clinic
  - Isehara city, Kanagawa pref., Japan
    - Akizawa Clinic
  - Isehara city, Kanagawa pref., Japan
    - Medical Corp Takeda Clinic
  - Kamakura city, Kanagawa pref., Japan
    - Hashimoto Clinic
  - Kamakura city, Kanagawa pref., Japan
    - Iroden Clinic
  - Kamakura city, Kanagawa pref., Japan
    - Kamakura Naika Shinryosyo
  - Kamakura city, Kanagawa pref., Japan
    - Shohei Clinic
  - Kawasaki city, Kanagawa pref., Japan
    - Hatori Medical Clinic
  - Kawasaki city, Kanagawa pref., Japan
    - Hirayasu Iin
  - Kawasaki city, Kanagawa pref., Japan
    - Kamegaya Medical Clinic
  - Kawasaki city, Kanagawa pref., Japan
    - Kirimura Iin
  - Odawara city, Kanagawa pref., Japan
    - Kojima Clinic
  - Sagamihara city, Kanagawa pref., Japan
    - Hakuai Iin
  - Sagamihara city, Kanagawa pref., Japan
    - Sato Clinic
  - Sagamihara city, Kanagawa pref., Japan
    - Toshiba Rinkan Hospital
  - Sagamihara city, Kanagawa pref., Japan
    - Yamamoto Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Fukumura Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Fukushi Clinic
  - Yokohama city, Kanagawa pref., Japan
    - International Goodwill Hospital
  - Yokohama city, Kanagawa pref., Japan
    - Kikuchi Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Matsuo Naika Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Miho-cho Cardiovascular Medical Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Minamisawa Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Miyoshi-Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Paula's Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Shimokurata Heart Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Shinwakai Fukuda Iin
  - Yokohama city, Kanagawa pref., Japan
    - Shinyoshida Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Suzuki Orthopedic Clinic
  - Yokohama city, Kanagawa pref., Japan
    - Yokohama City University Medical Center
  - Yokohama city, Kanagawa pref., Japan
    - Yokohama Sotetsu Bldg. Clinic of Internal Medicine
  - Yokosuka City, Kanagawa pref., Japan
    - Hara Clinic
- Kochi pref.
  - Kochi city, Kochi pref., Japan
    - Ueta Medical Clinic
- Kumamoto pref.
  - Amakusa city, Kumamoto pref., Japan
    - Nakayama Cardiovascular Clinic
  - Amakusa city, Kumamoto pref., Japan
    - Yamashita Clinic
  - Aso city, Kumamoto pref., Japan
    - National Health Insurance Central Hospital Aso
  - Aso city, Kumamoto pref., Japan
    - Sakanashi Heart Clinic
  - Kamimashiki gun, Kumamoto pref., Japan
    - Koyasako iin
  - Kikuchi city, Kumamoto pref., Japan
    - Kawaguchi Hospital
  - Kikuchi city, Kumamoto pref., Japan
    - Miyamoto Internal Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Doi Cardiovascular Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Doi Naika-ichoka Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Haraguchi Circular&Internal Medical Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Jinnouchi Clinic Diabetes Care Center
  - Kumamoto city, Kumamoto pref., Japan
    - Kiyota Junkanki Naika Iin
  - Kumamoto city, Kumamoto pref., Japan
    - Maki Cardiovascular Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Nozuhara Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Ootsuka Hospital
  - Kumamoto city, Kumamoto pref., Japan
    - Shono Heart Clinic
  - Kumamoto city, Kumamoto pref., Japan
    - Suefuji Naika Junkankika
  - Kumamoto city, Kumamoto pref., Japan
    - Suizenji Tohya Hospital
  - Kumamoto city, Kumamoto pref., Japan
    - TERAO Hospital
  - Kumamoto city, Kumamoto pref., Japan
    - Yi Medical Clinic
  - Shimomashiki gun, Kumamoto pref., Japan
    - Munakata Clinic
  - Tamana city, Kumamoto pref., Japan
    - Higashi Diabetes and Cardiovascular Clinic
  - Tamana city, Kumamoto pref., Japan
    - Yoshimura Jyunnkannkika Naika Iinn
  - Tamana gun, Kumamoto pref., Japan
    - Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary
  - Yatsushiro city, Kumamoto pref., Japan
    - Miyagi clinic cardiovascular medicine
- Kyoto pref.
  - Kizugawa-city, Kyoto pref., Japan
    - Koide Iin
  - Kyotanabe city, Kyoto pref., Japan
    - Sawai Medical Clinic
  - Kyoto city, Kyoto pref., Japan
    - Asamoto Clinic of Internal Medicine
  - Kyoto city, Kyoto pref., Japan
    - Gotoh Clinic
  - Kyoto city, Kyoto pref., Japan
    - Higashiyama Takeda Hospital
  - Kyoto city, Kyoto pref., Japan
    - Isoda Internal Medical Clinic
  - Kyoto city, Kyoto pref., Japan
    - Omoto Clinic
  - Kyoto city, Kyoto pref., Japan
    - Sakazaki Clinic
  - Kyoto city, Kyoto pref., Japan
    - Shinya Clinic
  - Kyoto city, Kyoto pref., Japan
    - Takagi Cardiology Clinic
  - Kyoto city, Kyoto pref., Japan
    - Takenaka Clinic
  - Kyoto city, Kyoto pref., Japan
    - Tegoshi Clinic
  - Yosa gun, Kyoto pref., Japan
    - Kimura Naika Clinic
- Mie pref.
  - Ise city, Mie pref., Japan
    - Shimizu Clinic
  - Nabari city, Mie pref., Japan
    - Horii Clinic Kiodai
- Miyagi pref.
  - Higashi matsushima city, Miyagi pref., Japan
    - Yamoto-naika Clinic
  - Kurokawa gun, Miyagi pref., Japan
    - Seisuikai Yoshioka QQ Clinic
  - Tome City, Miyagi pref., Japan
    - Ohtomo Clinic
- Nagano pref.
  - Shimoina gun, Nagano pref., Japan
    - Shimoina Kosei Hospital
  - Shiojiri city, Nagano pref., Japan
    - Yokoyama Medical Clinic
  - Suzaka city, Nagano pref., Japan
    - Sato Clinic
- Nagasaki pref.
  - Nagasaki city, Nagasaki pref., Japan
    - Hoshiko Clinic
  - Nagasaki city, Nagasaki pref., Japan
    - Shinagawa Clinic
  - Nishisonogi gun, Nagasaki pref., Japan
    - Iryohojin Yamamoto Naika
- Nara pref.
  - Gojo city, Nara pref., Japan
    - Yamada Clinic
  - Ikoma city, Nara pref., Japan
    - Uyama Naika Clinic
  - Kahihara city, Nara pref., Japan
    - Clinic Jinguumae
  - Kahihara city, Nara pref., Japan
    - Kasahara Clinic
  - Kashiba city, Nara pref., Japan
    - Sawada Clinic
  - Kashihara city, Nara pref., Japan
    - Doi Clinic
  - Kashihara city, Nara pref., Japan
    - Medical Corporation Kiriyama Clinic
  - Kashihara city, Nara pref., Japan
    - Miyamoto Clinic
  - Kashihara city, Nara pref., Japan
    - Oosumi Naika Iin
  - Kitakatsuragi gun, Nara pref., Japan
    - Kondo Clinic Mamigaoka Purified Center
  - Kitakatsuragi gun, Nara pref., Japan
    - Matsuoka Clinic
  - Kitakatsuragi gun, Nara pref., Japan
    - Nakahori Iin
  - Kitakatsuragi gun, Nara pref., Japan
    - Seiwadai Clinic
  - Nara city, Nara pref., Japan
    - Saiseikai Nara Hospital
  - Nara city, Nara pref., Japan
    - Takanohara Central Hospital
  - Nara city, Nara pref., Japan
    - Takanohara Suzuran-naika
  - Sakurai city, Nara pref., Japan
    - Ote Clinic of Internal Medicine
  - Sakurai city, Nara pref., Japan
    - Sakaguchi Clinic
  - Shiki gun, Nara pref., Japan
    - Kokuho Central Hospital
  - Yamatokoriyama city, Nara pref., Japan
    - Makiura Naika
  - Yamatokoriyama city, Nara pref., Japan
    - Matsuta Heart Clinic
  - Yamatotakada city, Nara pref., Japan
    - Nakatani Clinic
- Niigata pref.
  - Murakami city, Niigata pref., Japan
    - Sano Clinic
  - Nagaoka city, Niigata pref., Japan
    - Kawaguchi Clinic
  - Niigata city, Niigata pref., Japan
    - Maeda Medical Clinic
- Oiat pref.
  - Beppu city, Oiat pref., Japan
    - Watanabe NJ Clinic
  - Oita city, Oiat pref., Japan
    - Hirata Clinic
  - Oita city, Oiat pref., Japan
    - Ninomiya Clinic
  - Oita city, Oiat pref., Japan
    - Sumi Cardiology Clinic
  - Oita city, Oiat pref., Japan
    - Tokumaru Digestive Internal Medicine Clinic
  - Oita city, Oiat pref., Japan
    - Tsuzaki Clinic
  - Usa city, Oiat pref., Japan
    - Ishida Medical Clinic
- Okayama pref.
  - Kurashiki city, Okayama pref., Japan
    - Hachiouji Naika Clinic
  - Kurashiki city, Okayama pref., Japan
    - Inada Clinic
  - Okayama city, Okayama pref., Japan
    - Hisamatsu Medical Clinic
  - Okayama city, Okayama pref., Japan
    - Yuhara Naika Clinic
  - Setouchi city, Okayama pref., Japan
    - Hattori Clinic
- Osaka pref.
  - Fujiidera city, Osaka pref., Japan
    - Nishimura Clinic
  - Higashiosaka city, Osaka pref., Japan
    - Ikeda Clinic
  - Higashiosaka city, Osaka pref., Japan
    - Ogawa Clinic
  - Hirakata city, Osaka pref., Japan
    - Taisei Clinic
  - Ibaraki city, Osaka pref., Japan
    - Ishiga Clinic
  - Ibaraki city, Osaka pref., Japan
    - Masuda Clinic
  - Izumi city, Osaka pref., Japan
    - Kanazawa Clinic
  - Kaizuka city, Osaka pref., Japan
    - Misugi Clinic
  - Kaizuka city, Osaka pref., Japan
    - Yoshida Clinic
  - Kishiwada city, Osaka pref., Japan
    - Mori Iin
  - Moriguchi city, Osaka pref., Japan
    - Medical Corporation Joukokai Teranishi-geka naika
  - Osaka city, Osaka pref., Japan
    - Iryouhoujin Suisyoukai Murata Hospital
  - Osaka city, Osaka pref., Japan
    - Izuoka Clinic
  - Osaka city, Osaka pref., Japan
    - Keiju Hospital
  - Osaka city, Osaka pref., Japan
    - Kondo Clinic
  - Osaka city, Osaka pref., Japan
    - Kubota Clinic
  - Osaka city, Osaka pref., Japan
    - Matsushita Medical Clinic
  - Osaka city, Osaka pref., Japan
    - Nishizawa Clinic
  - Osaka city, Osaka pref., Japan
    - Osaka General Medical Center
  - Osaka city, Osaka pref., Japan
    - Senpuku Clinic
  - Osaka city, Osaka pref., Japan
    - Tai Internal Medicin Clinic
  - Osaka city, Osaka pref., Japan
    - Ueda Clinic
  - Sakai city, Osaka pref., Japan
    - Ohta Iin
  - Suita city, Osaka pref., Japan
    - Ban Clinic
  - Suita city, Osaka pref., Japan
    - Iryohojin Nogi Naika Iin
  - Suita city, Osaka pref., Japan
    - Kobayashi Clinic
  - Takaishi city, Osaka pref., Japan
    - Ichida Internal Clinic
  - Takaishi city, Osaka pref., Japan
    - Yada Clinic
  - Takatsuki city, Osaka pref., Japan
    - Ryo Clinic
  - Yao city, Osaka pref., Japan
    - Matsuo Clinic
- Saitama pref.
  - Ageo city, Saitama pref., Japan
    - Enomoto Clinic
  - Hanyu city, Saitama pref., Japan
    - Medimo Hanyu Clinic
  - Kawagoe city, Saitama pref., Japan
    - Hirose Hospital
  - Kawaguchi city, Saitama pref., Japan
    - Iryohojin Hogi Shinryojo
  - Kawaguchi city, Saitama pref., Japan
    - Tokutake Iin
  - Koshigaya city, Saitama pref., Japan
    - Gamo Tenjinbashi Clinic
  - Koshigaya city, Saitama pref., Japan
    - Matsumoto Clinic
  - Kumagaya city, Saitama pref., Japan
    - Medical Corporation Shibuya Clinic
  - Saitama city, Saitama pref., Japan
    - Akimoto Clinic
  - Saitama city, Saitama pref., Japan
    - Iwatsuki-minami Hospital
  - Saitama city, Saitama pref., Japan
    - Suzuhiro Clinic
  - Tokorozawa City, Saitama pref., Japan
    - Nashida naika clinic
- Shizuoka pref.
  - Shimoda city, Shizuoka pref., Japan
    - Shizuoka Medical Alliance Shirahama Chuou Clinic
  - Shizuoka city, Shizuoka pref., Japan
    - Akiyama Clinic
  - Shizuoka city, Shizuoka pref., Japan
    - Aoshima Clinic
  - Shizuoka city, Shizuoka pref., Japan
    - Eguchi Clinic
  - Shizuoka city, Shizuoka pref., Japan
    - Shizuoka Hospital
  - Yaizu city, Shizuoka pref., Japan
    - Ueno Clinic
- Tochigi pref.
  - Ohtawara city, Tochigi pref., Japan
    - Takahashi Medical Clinic
  - Oyama city, Tochigi pref., Japan
    - Iryouhoujin Yuukoukai Morioka Naika Shonika
  - Tochigi city, Tochigi pref., Japan
    - Takada Clinic
  - Utsunomiya city, Tochigi pref., Japan
    - Masuda Naika
- Tokushima pref.
  - Anan city, Tokushima pref., Japan
    - Murakami Clinic
  - Itano gun, Tokushima pref., Japan
    - Fukushima Clinic
  - Itano gun, Tokushima pref., Japan
    - Yamamoto Naika Ityoka
  - Kaifu gun, Tokushima pref., Japan
    - Yuki National Health Insurance Hospital of Minami Town
  - Komatsushima city, Tokushima pref., Japan
    - Sekishinkan Hospital
  - Myozai gun, Tokushima pref., Japan
    - Ueta Clinic
  - Tokushima city, Tokushima pref., Japan
    - Kensei Uchimachi Clinic
  - Tokushima city, Tokushima pref., Japan
    - Kitagawa Naika Ityoka
  - Tokushima city, Tokushima pref., Japan
    - Kitasako Clinic
  - Tokushima city, Tokushima pref., Japan
    - Limbs Tokushima Clinic
  - Tokushima city, Tokushima pref., Japan
    - Matsumura Internal, Gastrointestial Medicine
  - Tokushima city, Tokushima pref., Japan
    - Okagawa Clinic
  - Tokushima city, Tokushima pref., Japan
    - Yokoi Internal Medicine
  - Yoshinokawa city, Tokushima pref., Japan
    - Kimura Internal Medicine Clinic
  - Yoshinokawa city, Tokushima pref., Japan
    - Yata Clinic
- Tokyo
  - Akishima city, Tokyo, Japan
    - Okubo Clinic
  - Bunkyo ku, Tokyo, Japan
    - Juntendo University Hospital
  - Edogawa ku, Tokyo, Japan
    - Choei Clinic
  - Edogawa ku, Tokyo, Japan
    - Shiraishi Iin
  - Hachioji City, Tokyo, Japan
    - Utsugidai Tajima Clinic
  - Hachioji city, Tokyo, Japan
    - Hattori Clinic
  - Hachioji city, Tokyo, Japan
    - Toyoizumi Hospital
  - Itabashi ku, Tokyo, Japan
    - Mochizuki Naika Clinic
  - Itabashi ku, Tokyo, Japan
    - Nishio Clinic
  - Koto ku, Tokyo, Japan
    - Ono Heart Clinic
  - Minato-ku, Tokyo, Japan
    - Shiba Palace Clinic
  - Mitaka city, Tokyo, Japan
    - Kamada Clinic
  - Mitaka city, Tokyo, Japan
    - Tenjinmae Clinic
  - Mitaka-shi, Tokyo, Japan
    - Takayama Iin
  - Nerima ku, Tokyo, Japan
    - Sugawara Clinic
  - Ota-ku, Tokyo, Japan
    - Yamada Clinic
  - Setagaya ku, Tokyo, Japan
    - Matsumura Gastroenterological Clinic
  - Shinjuku ku, Tokyo, Japan
    - Magari Clinic
  - Shinjuku ku, Tokyo, Japan
    - Yotsuya Internal Medicine Clinic
  - Shinjuku ku, Tokyo, Japan
    - Yotsuya-Murakami Internal Medicine Clinic
  - Sumida city, Tokyo, Japan
    - Obayashi Clinic
  - Sumida ku, Tokyo, Japan
    - Sumidagawa Clinic
  - Tachikawa-shi, Tokyo, Japan
    - ISHII Medical Clinic
- Yamagata pref.
  - Murayama city, Yamagata pref., Japan
    - Takahashi Ko Minako Clinic
  - Obanazawa city, Yamagata pref., Japan
    - Obanazawa City Clinic
  - Obanazawa city, Yamagata pref., Japan
    - Okuyama Clinic
  - Obanazawa city, Yamagata pref., Japan
    - Sakae Clinic
  - Sakata city, Yamagata pref., Japan
    - Honma Clinic
  - Yamagata city, Yamagata pref., Japan
    - Isoda Clinic
  - Yamagata city, Yamagata pref., Japan
    - Nihei Clinic
  - Yamagata city, Yamagata pref., Japan
    - Shimasaki Clinic
  - Yamagata city, Yamagata pref., Japan
    - Yamagata Tokushukai Hospital
- Yamaguchi pref.
  - Iwakuni city, Yamaguchi pref., Japan
    - Iwasaki Naika Iin
  - Iwakuni city, Yamaguchi pref., Japan
    - Kuwahara Clinic
  - Shimonoseki city, Yamaguchi pref., Japan
    - Ayame Medical Clinic
  - Shimonoseki city, Yamaguchi pref., Japan
    - Johno Clinic
  - Shimonoseki city, Yamaguchi pref., Japan
    - Matsuda Medical Clinic
  - Shimonoseki city, Yamaguchi pref., Japan
    - Mizumachi Medical Clinic
  - Shimonoseki city, Yamaguchi pref., Japan
    - Noda Clinic
  - Ube City, Yamaguchi pref., Japan
    - Fujii Clinic
  - Ube City, Yamaguchi pref., Japan
    - Shakaiiryouhoujin Onaka Hospital
  - Ube city, Yamaguchi pref., Japan
    - Watada-naika Hospital
  - Yamaguchi city, Yamaguchi pref., Japan
    - Ouchi Clinic
- Yamanashi pref.
  - Chuo city, Yamanashi pref., Japan
    - Yoshizaki Clinic
  - Nishi Yatsushiro gun, Yamanashi pref., Japan
    - Takahashi Clinic
  - Tsuru city, Yamanashi pref., Japan
    - Higashikatsura Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients meeting the following inclusion criteria will be included in the study:

Patients giving voluntary written consent to participate in the study
Male or female patients 50 years of age or older (at informed consent)
Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)
Patients with two or more of the following risk factors
- Male
- 65 years of age or older
- Smoker
- L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
- Left ventricular hypertrophy
- First- or second-degree family history of MACE
- Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (<60 mL/min/1.73 m2)

Exclusion Criteria:

Patients meeting the following criteria will be excluded from the study:

Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
Patients judged to have familial hypercholesterolemia
Patients with a serum triglyceride level of ≥400 mg/dL
Patients with a history of myocardial infarction
Patients with a history of coronary revascularization (PCI or CABG)
Patients with a history of treatment of unstable angina
Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
Heart failure patients
Patients with a history of hypersensitivity to statins
Patients with a history of drug-induced myopathy
Patients with poorly controlled arrhythmia
Patients with severe liver or kidney disease
Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
Patients who are or may be pregnant
Patients judged by the investigators to be ineligible for participation in the study for any other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active comparator: Standard Pravastatin Group	Drug: Pravastatin 5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)
Active Comparator: Intensive Rosuvastatin Group	Drug: Rosuvastatin 5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)

Participant Group / Arm

Intervention / Treatment

Active Comparator: Active comparator: Standard Pravastatin Group

Drug: Pravastatin

5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)

Active Comparator: Intensive Rosuvastatin Group

Drug: Rosuvastatin

5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: At baseline	At baseline
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: 1 month after treatment initiation	1 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: 3 month after treatment initiation	3 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: 6 month after treatment initiation	6 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: 12 month after treatment initiation	12 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: 36 month after treatment initiation	36 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event Time Frame: At the end of the study or discontinuation up to 4 years	At the end of the study or discontinuation up to 4 years

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Positive Trial Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

June 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 30, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Hypercholesterolemia with concomitant type 2 diabetes and hypertension

Additional Relevant MeSH Terms

Other Study ID Numbers

0035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Time Frame
Prevention of individual MACE Time Frame: At baseline	At baseline
Prevention of MACE(combination of each category) Time Frame: At baseline	At baseline
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: At baseline	At baseline
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: At baseline	At baseline
Frequency and distribution of type of deaths during the study period Time Frame: At baseline	At baseline
Frequency and distribution of type of hospitalizations during the study period Time Frame: At baseline	At baseline
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: At baseline	At baseline
Frequency and type of adverse events Time Frame: At baseline	At baseline
Prevention of individual MACE Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Prevention of individual MACE Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Prevention of individual MACE Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Prevention of individual MACE Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Prevention of individual MACE Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Prevention of individual MACE Time Frame: At the end of the study (or discontinuation)	At the end of the study (or discontinuation)
Prevention of MACE(combination of each category) Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Prevention of MACE(combination of each category) Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Prevention of MACE(combination of each category) Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Prevention of MACE(combination of each category) Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Prevention of MACE(combination of each category) Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Prevention of MACE(combination of each category) Time Frame: At the end of the study (or discontinuation)	At the end of the study (or discontinuation)
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI) Time Frame: At study completion up to 4 years	At study completion up to 4 years
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio") Time Frame: At the end of the study or discontinuation up to 4 years	At the end of the study or discontinuation up to 4 years
Frequency and distribution of type of deaths during the study period Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Frequency and distribution of type of deaths during the study period Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Frequency and distribution of type of deaths during the study period Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Frequency and distribution of type of deaths during the study period Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Frequency and distribution of type of deaths during the study period Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Frequency and distribution of type of deaths during the study period Time Frame: At the end of the study or discontinuation up to 4 years	At the end of the study or discontinuation up to 4 years
Frequency and distribution of type of hospitalizations during the study period Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Frequency and distribution of type of hospitalizations during the study period Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Frequency and distribution of type of hospitalizations during the study period Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Frequency and distribution of type of hospitalizations during the study period Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Frequency and distribution of type of hospitalizations during the study period Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Frequency and distribution of type of hospitalizations during the study period Time Frame: At the end of the study or discontinuation up to 4 years	At the end of the study or discontinuation up to 4 years
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Frequency of other events (malignancy, dementia, need of nursing care) Time Frame: At the end of the study or discontinuation up to 4 years	At the end of the study or discontinuation up to 4 years
Frequency and type of adverse events Time Frame: 1 month after treatment initiation	1 month after treatment initiation
Frequency and type of adverse events Time Frame: 3 month after treatment initiation	3 month after treatment initiation
Frequency and type of adverse events Time Frame: 6 month after treatment initiation	6 month after treatment initiation
Frequency and type of adverse events Time Frame: 12 month after treatment initiation	12 month after treatment initiation
Frequency and type of adverse events Time Frame: 36 month after treatment initiation	36 month after treatment initiation
Frequency and type of adverse events Time Frame: At the end of the study or discontinuation up to 4 years	At the end of the study or discontinuation up to 4 years

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments (POSITIVE)

Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Anticipated)

Study Completion

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Hypertension

Clinical Trials on Pravastatin

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