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
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan plus Hydrochlorothiazide (Drug); Candesartan plus Hydrochlorothiazide (Drug); Amlodipine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceutical, Study Director, Affiliation: Sponsor GmbH
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 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.
Clinical Details
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Valsartan 160 mg Plus HCTZ 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Candesartan 32 mg) Plus HCTZ 25 mg
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Diastolic Blood Pressure (DBP) reduction by Valsartan + HCTZ in patients not adequately responding (i.e., DBP >= 90 mmHg) to 4 weeks of treatment with Candesartan + HCTZ in free combinationFor optional extension: DBP reduction by Valsartan + HCTZ + Amlodipine in patients not adequately responding (i.e., DBP >= 90 mmHg and/or Systolic Blood Pressure (SBP) >= 140 mmHg) to 4 weeks of treatment with angiotensin receptor blockers + HCTZ
Secondary outcome: SBP, pulse pressure, heart rate, normalization (DBP < 90 mmHg and/or SBP < 140 mmHg, resp.)and responder rate(DBP < 90 mmHg or reduction by at least 10 mmHg and/or SBP < 140 mmHg or reduction by at least 20 mmHg, rep)Safety and tolerability Compliance by pill count For optional extension: SBP, pulse pressure, heart rate, normalization and responder rate as defined above
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female patients (>=18 years)
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:
1. Severe hypertension (WHO)
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
Locations and Contacts
Investigative Centers, Germany
Novartis Pharmaceuticals, Basel, Switzerland
Additional Information
Starting date: July 2006
Last updated: November 7, 2011
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