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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Valsartan plus Hydrochlorothiazide
• Drug: Candesartan plus Hydrochlorothiazide
• Drug: Amlodipine

Primary Measures

• 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 combination
• For 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 Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceutical Study Director Sponsor GmbH  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00360178

Study ID Number: CVAH631BDE13

ClinicalTrials.gov Identifier: NCT00360178

Health Authority: Germany: Federal Institute for Drugs and Medical Devices