An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension

Novartis1 site in 1 country443 target enrollmentFebruary 2009

ConditionsHypertension

InterventionsAliskiren/Amlodipine Amlodipine

DrugsAliskiren/Amlodipine Amlodipine

Overview

Phase: Phase 4
Intervention: Aliskiren/Amlodipine
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 443
Locations: 1
Primary Endpoint: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

August 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men or women of African American background; self identified
•Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 5 (randomization

Exclusion Criteria

•Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
•Patients on 4 or more antihypertensive medications.
•Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1
•Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
•History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
•Evidence of a secondary form of hypertension, including but not limited to any of the following:
•coarctation of the aorta
•hyperaldosteronism
•unilateral or bilateral renal artery stenosis
•Cushing's disease

Arms & Interventions

Aliskiren/Amlodipine

Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg

Intervention: Aliskiren/Amlodipine

Amlodipine

Amlodipine 5mg titrated to 10 mg

Intervention: Amlodipine

Outcomes

Primary Outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Time Frame: Baseline, 8 weeks

To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.

Secondary Outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, 8 weeks)
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)(8 weeks)
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)(8 weeks)
Change From Baseline in MSSBP at Week 1 and 4(Baseline, 1 and 4 weeks)
Percentage of Patients With Peripheral Edema by Visit(8 weeks)