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

NCT00853957 | Completed Phase 4 Results

• 1 other identifier: CSPA100AUS01
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 9

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.

Conditions

Hypertension

Keywords

Hypertension; African Americans; Aliskiren; Amlodipine; Systolic blood pressure; Diastolic blood pressure; Stage II; Combination

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 8 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Aliskiren/Amlodipine

EXPERIMENTAL

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

Drug: Aliskiren/Amlodipine

Amlodipine

ACTIVE COMPARATOR

Amlodipine 5mg titrated to 10 mg

Drug: Amlodipine

Interventions

Aliskiren/Amlodipine DRUG

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

Aliskiren/Amlodipine

Amlodipine DRUG

Amlodipine 5 mg titrated to 10mg

Amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (9)

Investigative Site

Chicago, Illinois, United States

Location

Investigative Site

Baltimore, Maryland, United States

Location

Investigative Site

Oxon Hill, Maryland, United States

Location

Investigative Site

Detroit, Michigan, United States

Location

Investigative Site

Trenton, New Jersey, United States

Location

Investigative Site

Brooklyn, New York, United States

Location

Investigative Site

Springfield Gardens, New York, United States

Location

Investigative Site

Philadelphia, Pennsylvania, United States

Location

Investigative Site

Milwaukeee, Wisconsin, United States

Location

Related Publications (1)

• Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17.

  PMID: 21925996 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 30, 2012
• Results First Posted: January 21, 2011

Record last verified: 2012-04

Locations

US (9)