Hypertension
Conditions
Keywords
Hypertension, High blood pressure, diuretics, valsartan
Brief summary
This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.
Interventions
160/12.5 mg taken once daily orally
DRUGHCTZ
25 mg taken once daily orally
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 18 years of age and older * Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and \<110 mm Hg
Exclusion criteria
* \- Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg * Diabetes with fasting glucose \> 126 mg/dl or on existing anti-diabetic medication * History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks | — |
| Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic blood pressure after 2 weeks and 4 weeks | — |
| Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks | — |
| Change in systolic blood pressure at 20 weeks compared to 4 weeks | — |
| Change in diastolic blood pressure at 20 weeks compared to 4 weeks | — |
Countries
United States
Outcome results
None listed