Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors (CRUCIAL)

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice

To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1531

Phase

  • Phase 4

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

  • Costa Rica
      • Heredia, Costa Rica
        • Pfizer Investigational Site
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Desamparados, San Jose, Costa Rica
        • Pfizer Investigational Site
  • Croatia
      • Breznicki Hum, Croatia, 42225
        • Pfizer Investigational Site
      • Cakovec, Croatia, 40000
        • Pfizer Investigational Site
      • Crikvenica, Croatia, 51260
        • Pfizer Investigational Site
      • Karlovac, Croatia, 47000
        • Pfizer Investigational Site
      • Rijeka, Croatia, 51000
        • Pfizer Investigational Site
      • Spisic Bukovica, Croatia, 33404
        • Pfizer Investigational Site
      • Split, Croatia, 21000
        • Pfizer Investigational Site
      • Sv. Kriz Zacretje, Croatia, 49223
        • Pfizer Investigational Site
      • Varazdin, Croatia, 42000
        • Pfizer Investigational Site
      • Zagreb, Croatia, 10000
        • Pfizer Investigational Site
  • Czechia
      • Brno, Czechia, 656 91
        • Pfizer Investigational Site
      • Klatovy, Czechia, 339 01
        • Pfizer Investigational Site
      • Kralupy nad Vltavou, Czechia, 278 01
        • Pfizer Investigational Site
      • Lanskroun, Czechia, 563 01
        • Pfizer Investigational Site
      • Olomouc, Czechia, 779 00
        • Pfizer Investigational Site
      • Pelhrimov, Czechia, 393 01
        • Pfizer Investigational Site
      • Praha 4, Czechia, 141 00
        • Pfizer Investigational Site
      • Praha 8, Czechia, 186 00
        • Pfizer Investigational Site
      • Pruhonice, Czechia, 252 43
        • Pfizer Investigational Site
      • Usti nad Labem, Czechia, 400 07
        • Pfizer Investigational Site
      • Vratimov, Czechia, 739 32
        • Pfizer Investigational Site
      • Zlin 4, Czechia, 763 02
        • Pfizer Investigational Site
  • Dominican Republic
      • San Cristobal, Dominican Republic
        • Pfizer Investigational Site
      • Santo Domingo, Dominican Republic, 4966
        • Pfizer Investigational Site
      • Santo Domingo, Dominican Republic
        • Pfizer Investigational Site
  • Indonesia
      • Bandung, Indonesia, 40161
        • Pfizer Investigational Site
      • Jakarta, Indonesia, 10430
        • Pfizer Investigational Site
      • Jakarta, Indonesia, 11420
        • Pfizer Investigational Site
      • Semarang, Indonesia, 50231
        • Pfizer Investigational Site
      • Surabaya, Indonesia, 60286
        • Pfizer Investigational Site
      • Tangerang, Indonesia, 15224
        • Pfizer Investigational Site
      • Tanggerang, Indonesia, 15811
        • Pfizer Investigational Site
    • Jakarta Selatan
      • Cilandak, Jakarta Selatan, Indonesia, 12430
        • Pfizer Investigational Site
  • Jordan
      • Amman, Jordan, 11942
        • Pfizer Investigational Site
      • Amman, Jordan, 11181
        • Pfizer Investigational Site
      • Irbid, Jordan, 22110
        • Pfizer Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Pfizer Investigational Site
      • Busan, Korea, Republic of, 614-735
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 700-712
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 705-718
        • Pfizer Investigational Site
      • Daejeon, Korea, Republic of, 301-721
        • Pfizer Investigational Site
      • Gwangju, Korea, Republic of
        • Pfizer Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-040
        • Pfizer Investigational Site
      • Seoul,, Korea, Republic of, 150-713
        • Pfizer Investigational Site
      • Suwon, Korea, Republic of, 443-721
        • Pfizer Investigational Site
    • Gangwon-Do
      • Wonju-si, Gangwon-Do, Korea, Republic of, 220-701
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Pfizer Investigational Site
  • Kuwait
      • Kuwait, Kuwait
        • Pfizer Investigational Site
      • Sasat, Kuwait, 13110
        • Pfizer Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Pfizer Investigational Site
      • Jbeil, Lebanon
        • Pfizer Investigational Site
  • Malaysia
      • Butterworth, Malaysia, 13000
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 57000
        • Pfizer Investigational Site
    • Negeri Sembilan
      • Kuala Pilah, Negeri Sembilan, Malaysia, 72000
        • Pfizer Investigational Site
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Pfizer Investigational Site
      • Petaling Jaya, Selangor, Malaysia, 47301
        • Pfizer Investigational Site
  • Mexico
      • Durango, Mexico, 34078
        • Pfizer Investigational Site
      • San Luis Potosi, Mexico, 78200
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 10700
        • Pfizer Investigational Site
      • Mexico, DF, Mexico, 02720
        • Pfizer Investigational Site
      • Mexico, DF, Mexico, 07300
        • Pfizer Investigational Site
      • Mexico, DF, Mexico, 09220
        • Pfizer Investigational Site
    • Estado De Mexico
      • Toluca, Estado De Mexico, Mexico, 50010
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Pfizer Investigational Site
      • Guadalajara, Jalisco, Mexico, 44200
        • Pfizer Investigational Site
  • Panama
      • Panama, Panama
        • Pfizer Investigational Site
      • Panama City, Panama
        • Pfizer Investigational Site
  • Philippines
      • Makati City, Philippines, 1218
        • Pfizer Investigational Site
      • Manila, Philippines, 1000
        • Pfizer Investigational Site
      • Marikina City, Philippines
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1101
        • Pfizer Investigational Site
    • Metro Manila
      • San Juan, Metro Manila, Philippines
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 101953
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 1117292
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115093
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 117485
        • Pfizer Investigational Site
      • Saint Petersburg, Russian Federation, 199106
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 192242
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 196084
        • Pfizer Investigational Site
      • Smolensk, Russian Federation, 214018
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194291
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 190000
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 195067
        • Pfizer Investigational Site
      • Volgograd, Russian Federation, 400008
        • Pfizer Investigational Site
      • Voronezh, Russian Federation, 394053
        • Pfizer Investigational Site
  • Saudi Arabia
      • Riyadh 11426, Saudi Arabia, Riyadh 11426
        • Pfizer Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 833
        • Pfizer Investigational Site
      • Taichung, Taiwan, 407
        • Pfizer Investigational Site
      • Taichung, Taiwan, 402
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
      • Tainan, Taiwan, 710
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan, 231
        • Pfizer Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Pfizer Investigational Site
    • Bangkok
      • Rajthevee, Bangkok, Thailand, 10400
        • Pfizer Investigational Site
      • Saimai, Bangkok, Thailand, 10220
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Ankara, Turkey, 06600
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34390
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34098
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34087
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34296
        • Pfizer Investigational Site
      • Izmir, Turkey, 35340
        • Pfizer Investigational Site
      • Izmir, Turkey, 35360
        • Pfizer Investigational Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Pfizer Investigational Site
      • Al Ain, United Arab Emirates
        • Pfizer Investigational Site
      • Dubai, United Arab Emirates
        • Pfizer Investigational Site
  • Venezuela
    • Carabobo
      • Naguanagua/Valencia, Carabobo, Venezuela, 2001
        • Pfizer Investigational Site
    • Dtto Capital/Municipio Libertador
      • Caracas, Dtto Capital/Municipio Libertador, Venezuela, 1050
        • Pfizer Investigational Site
      • Caracas, Dtto Capital/Municipio Libertador, Venezuela, 1053
        • Pfizer Investigational Site
    • Estado Carabobo
      • Valencia, Estado Carabobo, Venezuela, 2001
        • Pfizer Investigational Site

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

35 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)

Exclusion Criteria:

  • Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
  • Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caduet
Open label caduet added to usual care regimen followed by investigators.
Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
Time Frame: Baseline, Month 12
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Framingham 10-year Risk of Total CHD at Month 4
Time Frame: Baseline, Month 4
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).
Baseline, Month 4
European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
Time Frame: Baseline, Month 12
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).
Baseline, Month 12
European SCORE 10-year Risk of Fatal CVD at Month 4
Time Frame: Baseline, Month 4
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).
Baseline, Month 4
Framingham 10-year Risk of Stroke at Month 12
Time Frame: Baseline, Month 12
Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Baseline, Month 12
Framingham 10-year Risk of Stroke at Month 4
Time Frame: Baseline, Month 4
Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Baseline, Month 4
Change From Baseline in Framingham 10-year Risk of Developing Total CHD
Time Frame: Baseline, Month 4, Month 12
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.
Baseline, Month 4, Month 12
Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
Time Frame: Baseline, Month 4, Month 12
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.
Baseline, Month 4, Month 12
Mean Systolic and Diastolic Blood Pressure at Month 4
Time Frame: Month 4
Month 4
Mean Systolic and Diastolic Blood Pressure at Month 12
Time Frame: Month 12
Month 12
Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
Time Frame: Baseline, Month 4
Baseline, Month 4
Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
Time Frame: Baseline, Month 4
Baseline, Month 4
Change From Baseline in SBP at Month 12
Time Frame: Baseline, Month 12
Baseline, Month 12
Change From Baseline in DBP at Month 12
Time Frame: Baseline, Month 12
Baseline, Month 12
Mean Lipid Parameters at Month 4
Time Frame: Month 4
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Month 4
Mean Lipid Parameters at Month 12
Time Frame: Month 12
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Month 12
Change From Baseline in Lipid Parameters at Month 4
Time Frame: Baseline, Month 4
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
Baseline, Month 4
Change From Baseline in Lipid Parameters at Month 12
Time Frame: Baseline, Month 12
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Baseline, Month 12
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
Time Frame: Month 4, Month 12
Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.
Month 4, Month 12
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
Time Frame: Month 4, Month 12
Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.
Month 4, Month 12
Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
Time Frame: Month 4, Month 12
Treatments indicative of prescribed medications other than study provided Caduet.
Month 4, Month 12
Number of Participants With Increase of Treatment Dosages After 4 Months.
Time Frame: Month 4
Treatments indicative of prescribed medications other than study provided Caduet.
Month 4

Collaborators and Investigators

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

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

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

Other Study ID Numbers

  • A3841047

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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