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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Aliskiren; Drug: Ramipril; Drug: Hydrochlorothiazide; Drug: Amlodipine

• Registration Number: NCT00368277
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-22
• Study First Submitted QC: 2006-08-22
• Study First Posted: 2006-08-24
• Study Start: 2006-09
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2010-12-14
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-28
• Last Update Submitted: 2011-02-28
• Results First Posted: 2011-03-25
• Last Update Posted: 2011-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 901

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren-based regimen	Aliskiren	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
Ramipril-based regimen	Ramipril	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
Ramipril-based regimen	Amlodipine	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
Aliskiren-based regimen	Hydrochlorothiazide	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
Aliskiren-based regimen	Amlodipine	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
Ramipril-based regimen	Hydrochlorothiazide	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Cough	Weeks 12 and 36
Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints	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	Baseline and week 36

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States