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.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliskiren 300 mg (Once a Day)

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.

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren supplied in 150 mg and 300 mg tablets.

Placebo to Aliskiren

Intervention Type DRUG

Placebo to Aliskiren matching 150 and 300 mg tablets

Aliskiren 150 mg (Twice a Day)

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.

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren supplied in 150 mg and 300 mg tablets.

Placebo to Aliskiren

Intervention Type DRUG

Placebo to Aliskiren matching 150 and 300 mg tablets

Interventions

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Aliskiren

Aliskiren supplied in 150 mg and 300 mg tablets.

Intervention Type DRUG

Placebo to Aliskiren

Placebo to Aliskiren matching 150 and 300 mg tablets

Intervention Type DRUG

Other Intervention Names

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Tekturna, Rasilez

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No