None listed
Conditions
Interventions
Aliskiren monotherapy arm:
• Low-dose sub-arm: Patients will receive aliskiren 150 mg throughout the study
duration, with optional addition of amlodipine and HCTZ in sequential steps after the
at
the week-8 visit, the dose of aliskiren 150 mg will be force titrated to aliskiren 300
mg followed by optional addition of amlodipine and HCTZ in sequential steps based
on MSSBP control
at the week-8 visit the dose of aliskiren 150 mg
will be force titrated to 300 mg, this will be followed by optional up-titration of
amlodipine 5 mg to 10 mg and addition of HCTZ in sequential s
at the
week-8 visit, the dose of ramipril 5 mg will be force titrated to ramipril 10 mg
fol
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: Male or female 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 (i.e., Visit 2 or Visit 201)
Exclusion criteria
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. Investigational and reference therapy: • Aliskiren monotherapy low-dose (aliskiren 150 mg) • Aliskiren monotherapy high-dose (aliskiren 300 mg) • Aliskiren dual therapy low-dose (aliskiren 150 mg + amlodipine 5 mg) • Aliskiren dual therapy high-dose (aliskiren 300 mg + amlodipine 5 mg) • Ramipril monotherapy low-dose (ramipril 5 mg) • Ramipril monotherapy high-dose (ramipril 10 mg) Optional addition/up-titration of amlodipine (5 mg/10 mg) and hydrochlorothiazide (12.5 mg/25 mg) will be based on systolic blood pressure control. Efficacy assessments: • Mean sitting systolic blood pressure (MSSBP) • Blood pressure control (MSSBP/MSDBP < 140/90 mmHg) Other assessments: • Physical examination • Vital signs • Height, weight and waist circumference • Laboratory evaluations • Electrocardiogram (ECG)
Countries
Argentina, Colombia, Germany, Hungary, Mexico, Peru, Poland, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactCESAR MIRANDA
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed