Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.

Novartis

Status and phase: Completed; Phase 4

Conditions: Essential Hypertension

Treatments: Drug: Aliskiren; Drug: Placebo to Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654875

CSPP100A2403

Details and patient eligibility

About

This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertension medication within 4 weeks of visit 1 must have an office cuff mean sitting Diastolic Blood pressure (msDBP) > 100 mmHg and < 110 mmHg at visit 1. If patient is receiving antihypertensive treatment, must have a cuff msDBP > 95 mmHg and < 110 mmHg at visit 1
• Prior to randomization, all patients must have an office cuff msDBP >or= 100 mmHg and <or = 110 mmHg.

Exclusion criteria

• Participation in another aliskiren trial or previous treatment with aliskiren during last 6 months and who qualified to be randomized or enrolled into the active drug treatment period
• Pregnant or nursing women
• Women of child bearing potential unwilling to use protocol specific contraceptive methods
• Office cuff blood pressure of msDBP ≥ 112 mmHg and/or mean sitting Systolic Blood Pressure (msSBP) ≥ 200 mmHg).
• Secondary form of hypertension
• History of heart failure New York Heart Association (NYHA Class II, III and IV)
• Previous history of hypertensive encephalopathy or stroke, transient ischemic attack (TIA), heart attack, coronary bypass surgery or any percutaneous coronary intervention (PCI)
• Elevated Serum potassium (> or = 5.3 mEq/L (mmol/L) at Visit 1
• Type 1 or Type 2 diabetes mellitus not well controlled
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

Aliskiren 300 mg (Once a Day)

Experimental group

Description:

Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.

Treatment:

Drug: Placebo to Aliskiren

Drug: Aliskiren

Aliskiren 150 mg (Twice a Day)

Experimental group

Description:

Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.

Treatment:

Drug: Placebo to Aliskiren

Drug: Aliskiren