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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00170989
Enrollment
2714
Registered
2005-09-15
Start date
2004-09-30
Completion date
2005-07-31
Last updated
2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, high blood pressure, valsartan, hydrochlorothiazide

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.

Interventions

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in diastolic blood pressure from baseline after 8 weeks

Secondary

MeasureTime frame
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

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026