Phase 4 Completed N=433 Randomized Double-blind Treatment

Nebivolol in Patients With Systolic Stage 2 Hypertension

Hypertension

Source: ClinicalTrials.gov NCT01057251 ↗

Enrolled (actual)

433

Serious AEs

0.9%

Results posted

Jan 2012

Primary outcomePrimary: Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy — -18.2; -12.3 mm Hg

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.