A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients
This study has been completed.
Information provided by (Responsible Party):
First received: October 9, 2006
Last updated: November 7, 2011
Last verified: November 2011
Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
Primary Outcome Measures:
- Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8.
Secondary Outcome Measures:
- Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
- Safety and tolerability
- Proportion of patients achieving a blood pressure control target at week 8
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or female outpatients 18 years old or older.
- Patients with a diagnosis of hypertension.
- Patients who are eligible and consent to participate in the study
- Severe hypertension
- Previous or current diagnosis of heart failure.
- History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- Other protocol-defined inclusion/exclusion criteria may apply
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386139
|East Hanover, New Jersey, United States, 07936 |
|Investigative Centers, Germany |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2006
||November 7, 2011
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
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