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
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension

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

External Links

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