A Randomized, Double-blind, Parallel Group, Active-controlled Study to Compare the Systolic Blood Pressure Lowering Efficacy of Aliskiren, Ramipril and a Combination of Aliskiren and Amlodipine, With an Initial 8-week Evaluation, Followed by a 2-3 Year Follow-up to Compare Long-term Safety of an Aliskiren-based Regimen to a Ramipril-based Regimen in Hypertensive Patients ≥ 65 Years of Age (ASSESS)

NCT01922141 Phase 4 WITHDRAWN

This study is designed to compare the blood pressure lowering efficacy of aliskiren, a combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to moderate hypertension. It will also compare the long-term safety of an aliskiren-based regimen to a ramipril-based regimen

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	WITHDRAWN
Start date	2015-05
Completion	2018-06

Conditions

• Hypertension

Interventions

• Aliskiren
• Amlodipine
• Ramipril
• Hydrochlorothiazide

Primary outcomes

• Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8 — Baseline, Week 8
  The change from baseline to week 8 in mean sitting systolic blood pressure will be analyzed for aliskiren monotherapy, dual therapy of aliskiren and amlodipine and ramipril monotherapy using ANCOVA model in which treatment arm, region and age (less than 75 and greater than or equal to 75 years) will be included as factors