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

Condition(s) targeted: Hypertension

Intervention: aliskiren/ramipril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean Sitting Systolic Blood Pressure lowering effect at baseline, week 12, week 36

Secondary outcome:

Mean sitting diastolic blood pressure (msDBP) lowering from baseline to week 12, week 36

Cough at 12 and 36 weeks

Adverse Events at 12 and 36 weeks

Quality of Life at 12 and 36 weeks as assessed by the Psychological General Well-Being Index (PGWBI) and the Medical Outcomes Study (MOS) Sleep Scale (Short Form

Safety and tolerability

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female outpatients 65 years old or older.

- Patients with mild to moderate systolic hypertension.

- Patients who are eligible and consent to participate in the study

Exclusion Criteria:

- Severe hypertension

- History of CVA, TIA, MI or bypass surgery in the last 6 months

- Severe heart failure, severe chronic kidney disease or severe liver disease.

Other protocol-defined inclusion/exclusion criteria may apply

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: September 2006
Ending date: February 2008
Last updated: May 30, 2008