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OpenTrials
Completed

NCT Number: NCT00368277

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aliskiren

Drug

Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning

Ramipril

Drug

Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning

Hydrochlorothiazide

Drug

Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Amlodipine

Drug

Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Percentage of Patients With Cough

    Time frame: Weeks 12 and 36

  2. 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

  3. Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36

    Time frame: Baseline and week 36

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 24, 2006
Registry last updated
Mar 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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