Hypertension
Conditions
Keywords
Stage 1, Stage 2, Hypertension, 1 year open label safety study
Brief summary
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
Interventions
DRUGNebivolol, Valsartan and Hydrochlorothiazide
Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients of age 18 years or above * Patients diagnosed with stage 1 or stage 2 essential hypertension * Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant
Exclusion criteria
* Secondary hypertension or severe hypertension * Clinically significant cardiovascular disease or heart failure * A medical contraindication to discontinuing a current antihypertensive therapy * History of Type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event Recording | From Baseline to Week 53 (Visit 16) |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic Blood Pressure (DBP). | From Baseline to Week 52 (Visit 15) |
| Systolic Blood Pressure (SBP) | From Baseline to Week 52 (Visit 15) |
Countries
United States
Outcome results
None listed