Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren/Amlodipine; Drug: Amlodipine

• Registration Number: NCT00853957
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-12-06
• Results First Submitted QC: 2010-12-22
• Results First Posted: 2011-01-21
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

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
  • polycystic kidney disease
  • pheochromocytoma

• Known Keith-Wagener grade III or IV hypertensive retinopathy.

• History of angioedema due to usage of an ARB or ACE inhibitor.

• History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months

Other protocol defined inclusion/exclusion criteria applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren/Amlodipine	Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Amlodipine	Amlodipine 5mg titrated to 10 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	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 Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Baseline, 8 weeks	To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) 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).
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)	8 weeks	Cumulative percentage of patients achieving BP control (\<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)	8 weeks	Cumulative percentage of responders (Responders are defined as patients with MSSBP \<140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Change From Baseline in MSSBP at Week 1 and 4	Baseline, 1 and 4 weeks	Compare the change from baseline in MSSBP at week 1 and 4
Percentage of Patients With Peripheral Edema by Visit	8 weeks	Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Milwaukeee, Wisconsin, United States