Clinical trial NCT01922141: Aliskiren Study of Safety and Efficacy in Senior Hypertensives
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypertension
Keywords: High blood pressure, stage 1 and 2 hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Number of patients with serious adverse events and adverse events
timeFrame: Baseline, Week 8, average 2.5 years
measure: Number of patients with hyperkalemia, hypotension and reduction of estimated glomerular filtration rate (eGFR)
timeFrame: Baseline, Week 8
measure: Change from baseline in mean sitting systolic blood pressure (MSSBP) at the end of double blind period
timeFrame: Baseline, end of double blind period (in average 2.5 years)
measure: Percentage of patients achieving blood pressure control
timeFrame: Baseline, Week 8, average 2.5 years
measure: Percentage of patients with major cardiovascular events
timeFrame: Average 2.5 years
measure: Number of patients with gastrointestinal tract cancer
timeFrame: Average 2.5 years
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: