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NCT00407537 Clinical Trial

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

Hypertension Clinical Trial

— CRUCIAL  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00407537
Other study ID # A3841047
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2007
Est. completion date October 2009

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1531
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 35 Years to 79 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Costa Rica Pfizer Investigational Site Desamparados San Jose
Costa Rica Pfizer Investigational Site Heredia
Costa Rica Pfizer Investigational Site San Jose
Croatia Pfizer Investigational Site Breznicki Hum
Croatia Pfizer Investigational Site Cakovec
Croatia Pfizer Investigational Site Crikvenica
Croatia Pfizer Investigational Site Karlovac
Croatia Pfizer Investigational Site Rijeka
Croatia Pfizer Investigational Site Spisic Bukovica
Croatia Pfizer Investigational Site Split
Croatia Pfizer Investigational Site Sv. Kriz Zacretje
Croatia Pfizer Investigational Site Varazdin
Croatia Pfizer Investigational Site Zagreb
Czechia Pfizer Investigational Site Brno
Czechia Pfizer Investigational Site Klatovy
Czechia Pfizer Investigational Site Kralupy nad Vltavou
Czechia Pfizer Investigational Site Lanskroun
Czechia Pfizer Investigational Site Olomouc
Czechia Pfizer Investigational Site Pelhrimov
Czechia Pfizer Investigational Site Praha 4
Czechia Pfizer Investigational Site Praha 8
Czechia Pfizer Investigational Site Pruhonice
Czechia Pfizer Investigational Site Usti nad Labem
Czechia Pfizer Investigational Site Vratimov
Czechia Pfizer Investigational Site Zlin 4
Dominican Republic Pfizer Investigational Site San Cristobal
Dominican Republic Pfizer Investigational Site Santo Domingo
Dominican Republic Pfizer Investigational Site Santo Domingo
Indonesia Pfizer Investigational Site Bandung
Indonesia Pfizer Investigational Site Cilandak Jakarta Selatan
Indonesia Pfizer Investigational Site Jakarta
Indonesia Pfizer Investigational Site Jakarta
Indonesia Pfizer Investigational Site Semarang
Indonesia Pfizer Investigational Site Surabaya
Indonesia Pfizer Investigational Site Tangerang
Indonesia Pfizer Investigational Site Tanggerang
Jordan Pfizer Investigational Site Amman
Jordan Pfizer Investigational Site Amman
Jordan Pfizer Investigational Site Irbid
Korea, Republic of Pfizer Investigational Site Busan
Korea, Republic of Pfizer Investigational Site Busan
Korea, Republic of Pfizer Investigational Site Daegu
Korea, Republic of Pfizer Investigational Site Daegu
Korea, Republic of Pfizer Investigational Site Daejeon
Korea, Republic of Pfizer Investigational Site Gwangju
Korea, Republic of Pfizer Investigational Site Incheon
Korea, Republic of Pfizer Investigational Site Seongnam-si Gyeonggi-do
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul,
Korea, Republic of Pfizer Investigational Site Suwon
Korea, Republic of Pfizer Investigational Site Wonju-si Gangwon-Do
Kuwait Pfizer Investigational Site Kuwait
Kuwait Pfizer Investigational Site Sasat
Lebanon Pfizer Investigational Site Beirut
Lebanon Pfizer Investigational Site Jbeil
Malaysia Pfizer Investigational Site Batu Caves Selangor
Malaysia Pfizer Investigational Site Butterworth
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kuala Pilah Negeri Sembilan
Malaysia Pfizer Investigational Site Petaling Jaya Selangor
Malaysia Pfizer Investigational Site Seremban Negeri Sembilan
Mexico Pfizer Investigational Site Durango
Mexico Pfizer Investigational Site Guadalajara Jalisco
Mexico Pfizer Investigational Site Guadalajara Jalisco
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site San Luis Potosi
Mexico Pfizer Investigational Site Toluca Estado De Mexico
Panama Pfizer Investigational Site Panama
Panama Pfizer Investigational Site Panama City
Philippines Pfizer Investigational Site Makati City
Philippines Pfizer Investigational Site Manila
Philippines Pfizer Investigational Site Marikina City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site San Juan Metro Manila
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Saint Petersburg
Russian Federation Pfizer Investigational Site Saint-Petersburg
Russian Federation Pfizer Investigational Site Saint-Petersburg
Russian Federation Pfizer Investigational Site Smolensk
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site Volgograd
Russian Federation Pfizer Investigational Site Voronezh
Saudi Arabia Pfizer Investigational Site Riyadh 11426
Taiwan Pfizer Investigational Site Kaohsiung
Taiwan Pfizer Investigational Site Kaohsiung
Taiwan Pfizer Investigational Site Taichung
Taiwan Pfizer Investigational Site Taichung
Taiwan Pfizer Investigational Site Tainan
Taiwan Pfizer Investigational Site Tainan
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
Thailand Pfizer Investigational Site Bangkok
Thailand Pfizer Investigational Site Rajthevee Bangkok
Thailand Pfizer Investigational Site Saimai Bangkok
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Izmir
Turkey Pfizer Investigational Site Izmir
United Arab Emirates Pfizer Investigational Site Abu Dhabi
United Arab Emirates Pfizer Investigational Site Al Ain
United Arab Emirates Pfizer Investigational Site Dubai
Venezuela Pfizer Investigational Site Caracas Dtto Capital/Municipio Libertador
Venezuela Pfizer Investigational Site Caracas Dtto Capital/Municipio Libertador
Venezuela Pfizer Investigational Site Naguanagua/Valencia Carabobo
Venezuela Pfizer Investigational Site Valencia Estado Carabobo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Costa Rica,  Croatia,  Czechia,  Dominican Republic,  Indonesia,  Jordan,  Korea, Republic of,  Kuwait,  Lebanon,  Malaysia,  Mexico,  Panama,  Philippines,  Russian Federation,  Saudi Arabia,  Taiwan,  Thailand,  Turkey,  United Arab Emirates,  Venezuela, 

Outcome
Type Measure Description Time frame Safety issue
Primary Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at 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 Framingham 10-year Risk of Total CHD at 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
Secondary European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at 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
Secondary European SCORE 10-year Risk of Fatal CVD at 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
Secondary Framingham 10-year Risk of Stroke at 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
Secondary Framingham 10-year Risk of Stroke at 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
Secondary Change From Baseline in Framingham 10-year Risk of Developing Total CHD 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
Secondary Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD 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
Secondary Mean Systolic and Diastolic Blood Pressure at Month 4 Month 4
Secondary Mean Systolic and Diastolic Blood Pressure at Month 12 Month 12
Secondary Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 Baseline, Month 4
Secondary Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 Baseline, Month 4
Secondary Change From Baseline in SBP at Month 12 Baseline, Month 12
Secondary Change From Baseline in DBP at Month 12 Baseline, Month 12
Secondary Mean Lipid Parameters at Month 4 Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Month 4
Secondary Mean Lipid Parameters at Month 12 Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Month 12
Secondary Change From Baseline in Lipid Parameters at 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
Secondary Change From Baseline in Lipid Parameters at Month 12 Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Baseline, Month 12
Secondary Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months 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
Secondary Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months 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
Secondary Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months Treatments indicative of prescribed medications other than study provided Caduet. Month 4, Month 12
Secondary Number of Participants With Increase of Treatment Dosages After 4 Months. Treatments indicative of prescribed medications other than study provided Caduet. Month 4
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External Links