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
NCT ID: NCT00360178
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2006-07-31
2006-12-31
Brief Summary
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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 combination of Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of the core study can be treated with valsartan plus HCTZ in fixed dose combination plus amlodipine 5 mg for additional 4 weeks.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Valsartan plus Hydrochlorothiazide
Candesartan plus Hydrochlorothiazide
Amlodipine
Eligibility Criteria
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Inclusion Criteria
2. Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. intra-uterine device, hormonal contraceptives).
3. Patients with moderate essential hypertension (WHO):
Exclusion Criteria
2. Pregnant or nursing women
3. Treated hypertensive patients with controlled hypertension under current therapy (MSDBP \< 90 mmHg and MSSBP \< 140 mmHg)
4. 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
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceutical
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Investigative Centers, , Germany
Novartis Pharmaceuticals
Basel, , Switzerland
Countries
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References
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Schweizer J, Hilsmann U, Neumann G, Handrock R, Klebs S. Efficacy and safety of valsartan 160/HCTZ 25 mg in fixed combination in hypertensive patients not controlled by candesartan 32 mg plus HCTZ 25 mg in free combination. Curr Med Res Opin. 2007 Nov;23(11):2877-85. doi: 10.1185/030079907x242539.
Other Identifiers
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CVAH631BDE13
Identifier Type: -
Identifier Source: org_study_id