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.
Completed · Phase 4 · Has a placebo group
Conditions studied: Essential Hypertension
In brief
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
Key facts
- Study ID
- NCT00654875
- Run by
- Novartis
- People needed
- 328
- Starts
- 2008-03-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2011-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Investigative Site — Zanesville, Ohio, United States
- Investigative Site — Frankfurt, Germany
- Investigative Site — Valencia, Spain
Full record on ClinicalTrials.gov
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