Back to results

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

Primary Purpose

Hypertension, Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Amlodipine besylate/atorvastatin calcium single pill combination

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

35 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caduet

Arm Description

Open label caduet added to usual care regimen followed by investigators.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Framingham 10-year Risk of Total CHD at Month 4

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).

European SCORE 10-year Risk of Fatal CVD at Month 4

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).

Framingham 10-year Risk of Stroke at Month 4

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.

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.

Mean Systolic and Diastolic Blood Pressure at Month 4

Mean Systolic and Diastolic Blood Pressure at Month 12

Change From Baseline in Systolic Blood Pressure (SBP) at Month 4

Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4

Change From Baseline in SBP at Month 12

Change From Baseline in DBP at Month 12

Mean Lipid Parameters at Month 4

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

Mean Lipid Parameters at Month 12

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

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.

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.

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.

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.

Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months

Treatments indicative of prescribed medications other than study provided Caduet.

Number of Participants With Increase of Treatment Dosages After 4 Months.

Treatments indicative of prescribed medications other than study provided Caduet.

Full Information

NCT ID

NCT00407537

First Posted

December 1, 2006

Last Updated

January 26, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00407537

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1531 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Caduet

Arm Type

Experimental

Arm Description

Open label caduet added to usual care regimen followed by investigators.

Intervention Type

Drug

Intervention Name(s)

Amlodipine besylate/atorvastatin calcium single pill combination

Intervention Description

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

Primary Outcome Measure Information:

Title

Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12

Description

Time Frame

Baseline, Month 12

Secondary Outcome Measure Information:

Title

Framingham 10-year Risk of Total CHD at Month 4

Description

Time Frame

Baseline, Month 4

Title

European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12

Description

Time Frame

Baseline, Month 12

Title

European SCORE 10-year Risk of Fatal CVD at Month 4

Description

Time Frame

Baseline, Month 4

Title

Framingham 10-year Risk of Stroke at Month 12

Description

Time Frame

Baseline, Month 12

Title

Framingham 10-year Risk of Stroke at Month 4

Description

Time Frame

Baseline, Month 4

Title

Change From Baseline in Framingham 10-year Risk of Developing Total CHD

Description

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.

Time Frame

Baseline, Month 4, Month 12

Title

Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD

Description

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.

Time Frame

Baseline, Month 4, Month 12

Title

Mean Systolic and Diastolic Blood Pressure at Month 4

Time Frame

Month 4

Title

Mean Systolic and Diastolic Blood Pressure at Month 12

Time Frame

Month 12

Title

Change From Baseline in Systolic Blood Pressure (SBP) at Month 4

Time Frame

Baseline, Month 4

Title

Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4

Time Frame

Baseline, Month 4

Title

Change From Baseline in SBP at Month 12

Time Frame

Baseline, Month 12

Title

Change From Baseline in DBP at Month 12

Time Frame

Baseline, Month 12

Title

Mean Lipid Parameters at Month 4

Description

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

Time Frame

Month 4

Title

Mean Lipid Parameters at Month 12

Description

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

Time Frame

Month 12

Title

Change From Baseline in Lipid Parameters at Month 4

Description

Time Frame

Baseline, Month 4

Title

Change From Baseline in Lipid Parameters at Month 12

Description

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

Time Frame

Baseline, Month 12

Title

Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months

Description

Time Frame

Month 4, Month 12

Title

Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months

Description

Time Frame

Month 4, Month 12

Title

Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months

Description

Treatments indicative of prescribed medications other than study provided Caduet.

Time Frame

Month 4, Month 12

Title

Number of Participants With Increase of Treatment Dosages After 4 Months.

Description

Treatments indicative of prescribed medications other than study provided Caduet.

Time Frame

Month 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Desamparados

State/Province

San Jose

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

Heredia

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

San Jose

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

Breznicki Hum

ZIP/Postal Code

42225

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Cakovec

ZIP/Postal Code

40000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Crikvenica

ZIP/Postal Code

51260

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Spisic Bukovica

ZIP/Postal Code

33404

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Sv. Kriz Zacretje

ZIP/Postal Code

49223

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Varazdin

ZIP/Postal Code

42000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Pfizer Investigational Site

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Klatovy

ZIP/Postal Code

339 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Kralupy nad Vltavou

ZIP/Postal Code

278 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Lanskroun

ZIP/Postal Code

563 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Pelhrimov

ZIP/Postal Code

393 01

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Praha 4

ZIP/Postal Code

141 00

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Praha 8

ZIP/Postal Code

186 00

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Pruhonice

ZIP/Postal Code

252 43

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Usti nad Labem

ZIP/Postal Code

400 07

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Vratimov

ZIP/Postal Code

739 32

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Zlin 4

ZIP/Postal Code

763 02

Country

Czechia

Facility Name

Pfizer Investigational Site

City

San Cristobal

Country

Dominican Republic

Facility Name

Pfizer Investigational Site

City

Santo Domingo

ZIP/Postal Code

4966

Country

Dominican Republic

Facility Name

Pfizer Investigational Site

City

Santo Domingo

Country

Dominican Republic

Facility Name

Pfizer Investigational Site

City

Cilandak

State/Province

Jakarta Selatan

ZIP/Postal Code

12430

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Bandung

ZIP/Postal Code

40161

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Jakarta

ZIP/Postal Code

11420

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Semarang

ZIP/Postal Code

50231

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Surabaya

ZIP/Postal Code

60286

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Tangerang

ZIP/Postal Code

15224

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Tanggerang

ZIP/Postal Code

15811

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Amman

ZIP/Postal Code

11181

Country

Jordan

Facility Name

Pfizer Investigational Site

City

Amman

ZIP/Postal Code

11942

Country

Jordan

Facility Name

Pfizer Investigational Site

City

Irbid

ZIP/Postal Code

22110

Country

Jordan

Facility Name

Pfizer Investigational Site

City

Wonju-si

State/Province

Gangwon-Do

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Busan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Daegu

ZIP/Postal Code

705-718

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Gwangju

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul,

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

137-040

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Suwon

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Kuwait

Country

Kuwait

Facility Name

Pfizer Investigational Site

City

Sasat

ZIP/Postal Code

13110

Country

Kuwait

Facility Name

Pfizer Investigational Site

City

Beirut

Country

Lebanon

Facility Name

Pfizer Investigational Site

City

Jbeil

Country

Lebanon

Facility Name

Pfizer Investigational Site

City

Kuala Pilah

State/Province

Negeri Sembilan

ZIP/Postal Code

72000

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Seremban

State/Province

Negeri Sembilan

ZIP/Postal Code

70300

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Batu Caves

State/Province

Selangor

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Petaling Jaya

State/Province

Selangor

ZIP/Postal Code

47301

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Butterworth

ZIP/Postal Code

13000

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

57000

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

02720

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

07300

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

09220

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

10700

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Toluca

State/Province

Estado De Mexico

ZIP/Postal Code

50010

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44200

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Durango

ZIP/Postal Code

34078

Country

Mexico

Facility Name

Pfizer Investigational Site

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Panama City

Country

Panama

Facility Name

Pfizer Investigational Site

City

Panama

Country

Panama

Facility Name

Pfizer Investigational Site

City

San Juan

State/Province

Metro Manila

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Makati City

ZIP/Postal Code

1218

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Marikina City

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

101953

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

1117292

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

117485

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

190000

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Volgograd

ZIP/Postal Code

400008

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Voronezh

ZIP/Postal Code

394053

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Riyadh 11426

ZIP/Postal Code

Riyadh 11426

Country

Saudi Arabia

Facility Name

Pfizer Investigational Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Tainan

ZIP/Postal Code

710

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

231

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Rajthevee

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Saimai

State/Province

Bangkok

ZIP/Postal Code

10220

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Ankara

ZIP/Postal Code

06600

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34087

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34296

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Izmir

ZIP/Postal Code

35360

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Abu Dhabi

Country

United Arab Emirates

Facility Name

Pfizer Investigational Site

City

Al Ain

Country

United Arab Emirates

Facility Name

Pfizer Investigational Site

City

Dubai

Country

United Arab Emirates

Facility Name

Pfizer Investigational Site

City

Naguanagua/Valencia

State/Province

Carabobo

ZIP/Postal Code

2001

Country

Venezuela

Facility Name

Pfizer Investigational Site

City

Caracas

State/Province

Dtto Capital/Municipio Libertador

ZIP/Postal Code

1050

Country

Venezuela

Facility Name

Pfizer Investigational Site

City

Caracas

State/Province

Dtto Capital/Municipio Libertador

ZIP/Postal Code

1053

Country

Venezuela

Facility Name

Pfizer Investigational Site

City

Valencia

State/Province

Estado Carabobo

ZIP/Postal Code

2001

Country

Venezuela

12. IPD Sharing Statement

Citations:

PubMed Identifier

24339703

Citation

Cho EJ, Kim JH, Sutradhar S, Yunis C, Westergaard M; CRUCIAL Trial Investigators. Proactive multifactorial intervention strategy reduces the risk of cardiovascular disease estimated with region-specific risk assessment models in Pacific Asian patients participating in the CRUCIAL trial. J Korean Med Sci. 2013 Dec;28(12):1741-8. doi: 10.3346/jkms.2013.28.12.1741. Epub 2013 Nov 26.

Results Reference

derived

PubMed Identifier

23464930

Citation

Hradec J, Zamorano J, Sutradhar S. Post hoc analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial. Curr Med Res Opin. 2013 Jun;29(6):589-96. doi: 10.1185/03007995.2013.783795. Epub 2013 Apr 3.

Results Reference

derived

PubMed Identifier

22913893

Citation

Kim JH, Zamorano J, Erdine S, Pavia A, Al-Khadra A, Sutradhar S, Yunis C; CR UCIAL Investigators. Proactive cardiovascular risk management versus usual care in patients with and without diabetes mellitus: CRUCIAL trial subanalysis. Postgrad Med. 2012 Jul;124(4):41-53. doi: 10.3810/pgm.2012.07.2565.

Results Reference

derived

PubMed Identifier

21306285

Citation

Zamorano J, Erdine S, Pavia A, Kim JH, Al-Khadra A, Westergaard M, Sutradhar S, Yunis C; CRUCIAL Investigators. Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial. Curr Med Res Opin. 2011 Apr;27(4):821-33. doi: 10.1185/03007995.2011.555754. Epub 2011 Feb 10.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3841047&StudyName=Caduet%20vs%20Usual%20Care%20in%20Subjects%20with%20Hypertension%20and%20Additional%20Risk%20Factors

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Hypertension, Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial