Phase 4 N=245 Randomized Double-blind Treatment

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

Dyslipidemia · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00412113 ↗

Enrolled (actual)

245

Serious AEs

0.0%

Results posted

Nov 2009

Primary outcome: Primary: 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 — 11; 80 participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Amlodipine besylate (Drug); Amlodipine besylate/atorvastatin calcium single pill combination (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	11; 80	<0.001 sig
PRIMARY Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk	-0.1; -2.9	<0.001 sig
SECONDARY Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4	6; 73	<0.001 sig
SECONDARY Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.	41; 85	<0.001 sig
SECONDARY Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.	45; 90	<0.001 sig
SECONDARY Subjects With LDL-C < 100 mg/dL at Week 4	8; 96	<0.001 sig
SECONDARY Subjects With LDL-C < 100 mg/dL at Week 6	13; 99	<0.001 sig
SECONDARY Subjects With BP < 140/90 mmHg at Week 4	84; 87	0.785
SECONDARY Subjects With BP < 140/90 mmHg at Week 6	83; 94	0.171
SECONDARY Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).	-2.6; -1.5	0.585
SECONDARY Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)	-1.5; -1.2	> 0.999
SECONDARY Change From Baseline to Week 4 in Pulse Rate	-0.1; -0.9	0.363
SECONDARY Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)	-1.0; -4.0	0.020 sig
SECONDARY Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)	-1.1; -1.7	0.351
SECONDARY Change From Baseline to Week 6 in Pulse Rate	0.9; 1.1	0.922
SECONDARY Change From Baseline in LDL at Week 4.	-0.5; -47.8	<0.001 sig
SECONDARY Change From Baseline in High Density Lipoprotein (HDL) at Week 4.	0.6; 0.6	0.739
SECONDARY Change in Total Cholesterol (TC) From Baseline to Week 4.	0.5; -55.9	<0.001 sig
SECONDARY Change From Baseline in Triglycerides (TG) to Week 4.	2.4; -45.7	<0.001 sig
SECONDARY Change From Baseline in LDL at Week 6.	0.3; -49.2	<0.001 sig
SECONDARY Change From Baseline in HDL at Week 6.	1.2; 0.4	0.329
SECONDARY Change From Baseline in Total Cholesterol (TC) to Week 6.	3.7; -56.8	<0.001 sig
SECONDARY Change From Baseline in Triglycerides (TG) at Week 6.	11.6; -42.6	<0.001 sig
SECONDARY Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.	-0.3; -2.8	<0.001 sig

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00412113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.