Clinical trial NCT00412113: A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
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 (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-15
Enrollment: 245
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
timeFrame: Week 6
measure: Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
timeFrame: Week 6, baseline
Secondary outcomes:
measure: Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
timeFrame: Week 4
measure: Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.
timeFrame: Week 4
measure: Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.
timeFrame: Week 6
measure: Subjects With LDL-C < 100 mg/dL at Week 4
timeFrame: Week 4
measure: Subjects With LDL-C < 100 mg/dL at Week 6
timeFrame: Week 6
measure: Subjects With BP < 140/90 mmHg at Week 4
timeFrame: Week 4
measure: Subjects With BP < 140/90 mmHg at Week 6
timeFrame: Week 6
measure: Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
timeFrame: Week 4, baseline
measure: Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
timeFrame: Week 4, baseline
measure: Change From Baseline to Week 4 in Pulse Rate
timeFrame: Week 4, baseline
measure: Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
timeFrame: Week 6, baseline
measure: Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
timeFrame: Week 6, baseline
measure: Change From Baseline to Week 6 in Pulse Rate
timeFrame: Week 6, baseline
measure: Change From Baseline in LDL at Week 4.
timeFrame: Week 4, baseline
measure: Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
timeFrame: Week 4, baseline
measure: Change in Total Cholesterol (TC) From Baseline to Week 4.
timeFrame: Week 4, baseline
measure: Change From Baseline in Triglycerides (TG) to Week 4.
timeFrame: Week 4, baseline
measure: Change From Baseline in LDL at Week 6.
timeFrame: Week 6, baseline
measure: Change From Baseline in HDL at Week 6.
timeFrame: Week 6, baseline
measure: Change From Baseline in Total Cholesterol (TC) to Week 6.
timeFrame: Week 6, baseline
measure: Change From Baseline in Triglycerides (TG) at Week 6.
timeFrame: Week 6 , baseline
measure: Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
timeFrame: Week 4, baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Santa Margarita
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Safety Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Tucker
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Erlanger
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Auburn
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Warren
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Florissant
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Belvidere
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Bridgewater
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Clifton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Elizabeth
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Hillsborough
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Trenton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bensalem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Goose Creek
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Chesapeake
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: