Aliskiren Study of Safety and Efficacy in Senior Hypertensives (ASSESS)

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01922141

CSPP100A2370

2013-001562-42 (EudraCT Number)

Details and patient eligibility

About

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

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 65 years of age with a clinical diagnosis of essential hypertension at Visit 1.
• Mean sitting SBP (MSSBP) ≥ 140 mmHg and < 180 mmHg at Visit 2/Visit 201 and Visit 3.
• Absolute MSSBP difference ≤ 20 mmHg between Visit 3 and the Visit immediately prior

Exclusion criteria

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Severe hypertension (MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg) at Visit 1, Visit 2, Visit 201 or Visit 3 or during patient self measured blood pressure (SMBP) monitoring in the pre-randomization period confirmed by office measurement.
• Current treatment with any blocker of the renin angiotensin aldosterone system (RAAS) (aliskiren, ACE inhibitor, angiotensin receptor blocker or an aldosterone antagonist) and unable to discontinue this therapy.
• Concurrent use of any anti-hypertensive medications except a stable dose of 3 months prior to Visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., tamsulosin [Flomax®] for benign prostatic hypertrophy), beta blockers for angina, or beta blocker ophthalmic preparations.
• Contraindications to aliskiren, ramipril, amlodipine, or hydrochlorothiazide. Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Aliskiren monotherapy

Experimental group

Description:

Aliskiren 150 mg, once a day, force titrated to Aliskiren 300 mg after 8 weeks in 50% of patients. Optional addition/titration of amlodipine 5 mg/10 mg and hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps

Treatment:

Drug: Hydrochlorothiazide

Drug: Amlodipine

Drug: Aliskiren

Aliskiren dual therapy

Experimental group

Description:

Aliskiren 150 mg plus amlodipine 5 mg, once a day, force titrated to Aliskiren 300 mg plus amlodipine 5 mg after 8 weeks in 50% of patients. Optional titration of amlodipine 5 mg to 10 mg and optional addition/titration of hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps

Treatment:

Drug: Hydrochlorothiazide

Drug: Amlodipine

Drug: Aliskiren

Ramipril monotherapy

Active Comparator group

Description:

Ramipril 5 mg, once a day, force titrated to Ramipril 10 mg after 8 weeks in 50% of patients. Optional addition/titration of amlodipine 5 mg/10 mg and hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps

Treatment:

Drug: Ramipril

Drug: Hydrochlorothiazide

Drug: Amlodipine