Hypertension | Aliskiren Study of Safety and Efficacy in Senior Hypertensives
Hypertension research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AliskirenAliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
Drug:AmlodipineAmlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.
Drug:RamiprilRamipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
Drug:HydrochlorothiazideHydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Aliskiren monotherapyAliskiren 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
Aliskiren dual therapyAliskiren 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
Ramipril monotherapyRamipril 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
Start Date: May 2015
Completed Date: June 2018
Phase: Phase 4
Primary Outcome: Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8
Secondary Outcome: Number of patients with serious adverse events and adverse events
Study sponsors, principal investigator, and references
Principal Investigator: Novartis Pharmaceuticals
Lead Sponsor: Novartis Pharmaceuticals