A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Completed · Phase 3
Conditions studied: Hypertension
In brief
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).
Key facts
- Study ID
- NCT00386607
- Run by
- Novartis
- People needed
- 601
- Starts
- 2006-10-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2014-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
- Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
- History or evidence of a secondary form of hypertension.
- History of hypertensive encephalopathy or cerebrovascular accident.
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Investigative Centers — San Diego, California, United States
- Investigative Centers — Canada, Canada
- Investigative Centers — Germany, Germany
- Investigative Centers — Netherlands, Netherlands
Full record on ClinicalTrials.gov
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