Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia

The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.

Study Overview

• Status: Completed
• Conditions: Hypertension; Angina Pectoris; Hypercholesterolemia
• Intervention / Treatment: Drug: Caduet

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Yano Cardiovascular Clinic
  • Osaka, Japan
    • Nakaoka Clinic
  • Aichi
    • Nagoya, Aichi, Japan
      • Healthcare Corporation MEDOC Medical Dock&Clinic
  • Fukuoka
    • Dazaifu, Fukuoka, Japan
      • Beppu Medical Clinic
    • Kitakyushu, Fukuoka, Japan
      • Morizono medical clinic
    • Nishi-ku, Fukuoka, Japan
      • Gakkentoshi Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Department of internal gastro-intestinal medicine Ohshima clinic
  • Hyogo
    • Amagasaki, Hyogo, Japan
      • Oofuji Clinic
    • Kobe, Hyogo, Japan
      • Mizutani Clinic
    • Kobe, Hyogo, Japan
      • Nada Clinic
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Idaimae-naika Clinic
    • Yokohama, Kanagawa, Japan
      • Sakakibara Clinic, Wakaumekai Medical Corporation
  • Saitama
    • Fujimi, Saitama, Japan
      • Masunaga Clinic
    • Kawaguchi, Saitama, Japan
      • Sugiura Clinic
  • Tokyo
    • Adachi-ku, Tokyo, Japan
      • Masuda Clinic
    • Arakawa-ku, Tokyo, Japan
      • Wakasugi Family Clinic
    • Koto-ku, Tokyo, Japan
      • Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic
    • Ohta-ku, Tokyo, Japan
      • Banno Clinic
    • Setagaya-ku, Tokyo, Japan
      • Hatano Medical Clinic
    • Setagaya-ku, Tokyo, Japan
      • Suzuki Circulatory Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
• (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)
• (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
• (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
• Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
• (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
• (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
• (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2

Exclusion Criteria:

• Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.
• Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caduet	Drug: Caduet; One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Weeks 4, 12, 24, and 52
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Weeks 4, 12, 24, and 52
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Weeks 4, 12, 24, and 52
Percent Change From Baseline in Triglyceride (TG) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Week 4, 12, 24, and 52
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit	Value at each visits minus value at baseline	Weeks 4, 12, 24, and 52
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit	Value at each visits minus value at baseline	Weeks 4, 12, 24, and 52
Percent Change From Baseline in Apolipoprotein B at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Week 4, 12, 24, and 52

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 27, 2010

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Pain; Neurologic Manifestations; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Chest Pain; Hypertension; Hypercholesterolemia; Angina Pectoris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine, atorvastatin drug combination
• Other Study ID Numbers: A3841064