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A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemia, Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00412113
Pfizer
Completed
A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

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A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
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 (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Dyslipidemia
  • Hypertension
  • Drug: Amlodipine besylate
    Amlodipine besylate 5 mg
  • Drug: Amlodipine besylate/atorvastatin calcium single pill combination
    Amlodipine/atorvastatin single pill combination 10/20 mg
  • Drug: Amlodipine besylate
    Amlodipine besylate 10 mg
  • Drug: Amlodipine besylate/atorvastatin calcium single pill combination
    Amlodipine/atorvastatin single pill combination 5/20 mg
  • Active Comparator: Norvasc 5 mg
    Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.
    Intervention: Drug: Amlodipine besylate
  • Experimental: Caduet 10/20mg
    Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.
    Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
  • Active Comparator: Norvasc 10 mg
    Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.
    Intervention: Drug: Amlodipine besylate
  • Experimental: Caduet 5/20mg
    Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .
    Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
April 2008
April 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00412113
A3841045
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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