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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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 2, 2006
Last updated: November 16, 2016
Last verified: November 2016

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.

Condition Intervention Phase
Drug: Valsartan plus Hydrochlorothiazide
Drug: Candesartan plus Hydrochlorothiazide
Drug: Amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome 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 Outcome 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

Enrollment: 198
Study Start Date: July 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00360178

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceutical Sponsor GmbH
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT00360178     History of Changes
Other Study ID Numbers: CVAH631BDE13
Study First Received: August 2, 2006
Last Updated: November 16, 2016

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Angiotensin Receptor Antagonists
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors processed this record on May 22, 2017