Status:
COMPLETED
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Recruiting in Germany only: This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose combination in hypertensive patients not responding to treatment with the free combin...
Eligibility Criteria
Inclusion
- Male or female patients (\>=18 years)
- Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. intra-uterine device, hormonal contraceptives).
- Patients with moderate essential hypertension (WHO):
Exclusion
- Severe hypertension (WHO)
- Pregnant or nursing women
- Treated hypertensive patients with controlled hypertension under current therapy (MSDBP \< 90 mmHg and MSSBP \< 140 mmHg)
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00360178
Start Date
July 1 2006
End Date
December 1 2006
Last Update
November 18 2016
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland