A Multi-Risk Factor Strategy vs A Guideline-Based Approach In Achieving Blood Pressure & Lipid Goals In Hypertensives At Extra Risk - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00412113

Purpose

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus TLC regimen) will result in greater percentage of patients achieving blood pressure and LDL-C goals compared with a JNC 7/NCEP ATP III guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

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

MedlinePlus related topics: Calcium High Blood Pressure

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed To Evaluate The Efficacy Of An Aggressive Multi-Risk Factor Management Strategy With Caduet Versus A Guideline-Based Approach In Achieving Blood Pressure And Lipid Goals In Hypertensive Subjects With Additional Risk Factors.

Further study details as provided by Pfizer:

Primary Outcome Measures:

The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 6. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Framingham predicted 10-year risk of CHD outcomes based on subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure collected at Week 4 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
& 6. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The percentage of subjects achieving BP goal < 140/90 mmHg at Week 4 and 6. [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]
The change from Baseline in LDL-C, TC, triglycerides, HDL-C, HDL-C/LDL-C ratio, SBP, diastolic blood pressure, and pulse rate at Week 4 and 6. [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]
The safety profile of Caduet plus TLC based regimen versus Norvasc plus TLC based regimen. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The percentage of subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III Update LDL-C goal <100 mg/dL at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The percentage of subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4 and Week 6. [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]
The percentage of subjects achieving LDL-C goal < 100 mg/dL at Week 4 and 6. [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	245
Study Start Date:	January 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Caduet 10/20mg: Experimental Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.	Drug: Amlodipine besylate/atorvastatin calcium single pill combination Amlodipine/atorvastatin single pill combination 10/20 mg
Norvasc 10 mg: Active Comparator Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.	Drug: Amlodipine besylate Amlodipine besylate 10 mg
Norvasc 5 mg: Active Comparator Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.	Drug: Amlodipine besylate Amlodipine besylate 5 mg
Caduet 5/20mg: Experimental Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .	Drug: Amlodipine besylate/atorvastatin calcium single pill combination Amlodipine/atorvastatin single pill combination 5/20 mg

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion Criteria:

Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412113

Show 49 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:	A3841045
Study First Received:	December 13, 2006
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00412113
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Metabolic Diseases
Vascular Diseases
Metabolic disorder
Aggression

Atorvastatin
Dyslipidemias
Amlodipine
Lipid Metabolism Disorders
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 14, 2009