Status:
COMPLETED
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.
Lead Sponsor:
Novartis
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00654875
Start Date
March 1 2008
End Date
November 1 2008
Last Update
June 28 2011
Active Locations (3)
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1
Investigative Site
Zanesville, Ohio, United States
2
Investigative Site
Frankfurt, Germany
3
Investigative Site
Valencia, Spain