Text Size

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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00360178
First received: August 2, 2006
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Hypertension
 Drug: Valsartan plus Hydrochlorothiazide
Drug: Candesartan plus Hydrochlorothiazide
Drug: Amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360178

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00360178     History of Changes
Other Study ID Numbers: CVAH631BDE13
Study First Received: August 2, 2006
Last Updated: November 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
hypertension
valsartan
amlodipine
hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Candesartan
Candesartan cilexetil
Valsartan
Amlodipine
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on June 18, 2013