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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170989
• Other study ID #: CVAH631C2302
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2005
• Last updated: November 7, 2011
• Start date: September 2004
• Est. completion date: July 2005

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2714
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan plus hydrochlorothiazide

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in diastolic blood pressure from baseline after 8 weeks
Secondary	Change from baseline in systolic blood pressure from baseline after 8 weeks
Secondary	Change from baseline in standing systolic and diastolic blood pressure after 8 weeks
Secondary	Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks
Secondary	Diastolic blood pressure less than 90 mmHg after 8 weeks
Secondary	Adverse events and serious adverse events at 8 weeks