Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone

• ClinicalTrials.gov Identifier: NCT00170989
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: November 8, 2011
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Tracking Information

• First Submitted Date: September 10, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: November 8, 2011
• Study Start Date: September 2004
• Actual Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 1, 2006): Change from baseline in diastolic blood pressure from baseline after 8 weeks
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 1, 2006)

• Change from baseline in systolic blood pressure from baseline after 8 weeks
• Change from baseline in standing systolic and diastolic blood pressure after 8 weeks
• Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks
• Diastolic blood pressure less than 90 mmHg after 8 weeks
• Adverse events and serious adverse events at 8 weeks

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone
• Official Title: Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg
• Brief Summary: This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Hypertension
• Intervention: Drug: valsartan plus hydrochlorothiazide
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 7, 2011): 2714
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2005
• Actual Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with mild to moderate hypertension

Exclusion Criteria:

• Severe hypertension
• History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
• Liver, kidney, or pancreas disease
• Insulin dependent diabetes
• Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Switzerland

Administrative Information

• NCT Number: NCT00170989
• Other Study ID Numbers: CVAH631C2302
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis
• Original Responsible Party: Not Provided
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: June 2006