NCT01057251
Completed
Phase 4
Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension
Forest Laboratories36 sites in 1 country433 target enrollmentMarch 2010
Overview
- Phase
- Phase 4
- Intervention
- Nebivolol
- Conditions
- Hypertension
- Sponsor
- Forest Laboratories
- Enrollment
- 433
- Locations
- 36
- Primary Endpoint
- Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •male of female, 18 to 64 years of age at screening
- •mean seated heart rate at least 60 bpm
- •diagnosed systolic stage 2 hypertension
- •unremarkable physical exam findings
Exclusion Criteria
- •high risk due to secondary hypertension or former stage 3 hypertension by JNC6
- •concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
- •currently taking medication that cannot be stopped during the course of the study
- •participating other clinical trials
- •member of the study center personnel
- •documented drug abuse
- •contra indication to beta blocker
- •abnormal lab finding
- •poor compliance
- •other conditions judged by investigator that is not suitable for the study
Arms & Interventions
1
Intervention: Nebivolol
2
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Time Frame: Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)
Office blood pressure measured at trough by automatic oscillometric device.
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy
Time Frame: Change from Baseline (Week 0) to Visit 4 (Week 6)
Office blood pressure measured at trough by automatic oscillometric device.
Study Sites (36)
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