Aliskiren Study of Safety and Efficacy in Senior Hypertensives (NCT01922141) | Clinical Trial Compass
WithdrawnPhase 4
Aliskiren Study of Safety and Efficacy in Senior Hypertensives
0Started 2015-05
Plain-language 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
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8