Phase 4
N=433
Nebivolol in Patients With Systolic Stage 2 Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01057251 ↗Enrolled (actual)
433
Serious AEs
0.9%
Results posted
Jan 2012
Primary outcome: Primary: Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy — -18.2; -12.3 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nebivolol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy |
-18.2; -12.3 | — |
| PRIMARY Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy |
-12.3; -5.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01057251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.