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

• ClinicalTrials.gov Identifier: NCT00360178
• Recruitment Status: Completed
• First Posted: August 4, 2006
• Last Update Posted: November 18, 2016
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Valsartan plus Hydrochlorothiazide; Drug: Candesartan plus Hydrochlorothiazide; Drug: Amlodipine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 198 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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 :

1. 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)
2. Safety and tolerability
3. Compliance by pill count
4. For optional extension: SBP, pulse pressure, heart rate, normalization and responder rate as defined above

Eligibility Criteria

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

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

Locations

Germany

Investigative Centers, Germany

Switzerland

Novartis Pharmaceuticals

Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

• Study Director: Novartis Pharmaceutical; Sponsor GmbH

More Information

Additional Information:

Results for CVAH631BDE13 from the Novartis Clinical Trials website 

Publications of Results:

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.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00360178 History of Changes
• Other Study ID Numbers: CVAH631BDE13
• First Posted: August 4, 2006
• Last Update Posted: November 18, 2016
• Last Verified: November 2016

Keywords provided by Novartis:

hypertension; valsartan; amlodipine; hydrochlorothiazide

Additional relevant MeSH terms:

Valsartan; Hydrochlorothiazide; Hypertension; Vascular Diseases; Cardiovascular Diseases; Amlodipine; Candesartan; Candesartan cilexetil; Angiotensin Receptor Antagonists; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Diuretics; Natriuretic Agents; Sodium Chloride Symporter Inhibitors