Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00407537

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine besylate/atorvastatin calcium single pill combination	Phase IV

MedlinePlus related topics: Calcium High Blood Pressure

Drug Information available for: Atorvastatin Atorvastatin calcium Calcium gluconate Amlodipine Amlodipine besylate Caduet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary efficacy endpoint is the 10-year risk of developing total coronary heart disease using the Framingham Model at the end of 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood pressure and lipid parameters at 4 and 12 months. [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
10 year risk of developing stroke using the Framingham model for stroke at 4 and 12 months. [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
10-year risk of developing fatal CHD using the European SCORE model at 4 and 12 months. [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
10-year risk of developing total CHD using the Framingham Model at 4 months. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1968
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Caduet: Experimental 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

Eligibility

Ages Eligible for Study:	35 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407537

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 127 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3841047
Study First Received:	December 1, 2006
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00407537
Health Authority:	Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Atorvastatin
Amlodipine
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009