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

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”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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

Primary Measures

• Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No

Secondary Measures

• Percentage of Patients With Cough
  • Time Frame: Weeks 12 and 36
    Safety Issue?: Yes
• Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints
  • Time Frame: Weeks 12 and 36
    Safety Issue?: No
• Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36
  • Time Frame: Baseline and week 36
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368277

Study ID Number: CSPP100A2344

ClinicalTrials.gov Identifier: NCT00368277

Health Authority: United States: Food and Drug Administration