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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Hydrochlorothiazide; Drug: Ramipril; Drug: Amlodipine; Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00368277

CSPP100A2344

Details and patient eligibility

About

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.

Enrollment: 901 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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901 participants in 2 patient groups

Aliskiren-based regimen

Experimental group

Description:

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

Treatment:

Drug: Amlodipine

Drug: Aliskiren

Drug: Hydrochlorothiazide

Ramipril-based regimen

Active Comparator group

Description:

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

Treatment:

Drug: Amlodipine

Drug: Ramipril

Drug: Hydrochlorothiazide