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A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 22, 2006
Last updated: February 28, 2011
Last verified: February 2011
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

Condition Intervention Phase
Drug: Aliskiren
Drug: Ramipril
Drug: Hydrochlorothiazide
Drug: Amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 [ Time Frame: Baseline and Week 12 ]

Secondary Outcome Measures:
  • Percentage of Patients With Cough [ Time Frame: Weeks 12 and 36 ]
  • Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints [ Time Frame: Weeks 12 and 36 ]
    Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg

  • Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36 [ Time Frame: Baseline and week 36 ]

Enrollment: 901
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren-based regimen
Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
Drug: Aliskiren
Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning
Drug: Amlodipine
Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
Active Comparator: Ramipril-based regimen
Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
Drug: Ramipril
Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning
Drug: Amlodipine
Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female outpatients ≥ 65 years old.
  • Patients with essential hypertension with an msSBP ≥ 140 mmHg and < 180 mmHg, and msDBP < 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
  • Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
  • Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).

Exclusion Criteria:

  • History of renal artery stenosis.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy.
  • Current diagnosis of heart failure (New York Heart Association Class III-IV).
  • History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
  • History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
  • Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
  • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
  • Clinically significant valvular heart disease.
  • Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.
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Please refer to this study by its identifier: NCT00368277

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00368277     History of Changes
Other Study ID Numbers: CSPP100A2344
Study First Received: August 22, 2006
Results First Received: December 14, 2010
Last Updated: February 28, 2011

Keywords provided by Novartis:
Systolic hypertension
blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors processed this record on May 22, 2017