Phase 4 Completed N=277 Randomized Double-blind Treatment

A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

Hypertension

Source: ClinicalTrials.gov NCT00770861 ↗

Enrolled (actual)

277

Serious AEs

0.4%

Results posted

Jan 2011

Primary outcomePrimary: Change From Baseline in Trough Seated DBP at Week 8(LOCF). — -11.1; -7.3 mm Hg — p=<0.0001

Summary

This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Trough Seated DBP at Week 8(LOCF).	-11.1; -7.3	<0.0001 sig
SECONDARY Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).	-14.1; -9.3	0.001 sig

Eligibility Criteria

Inclusion Criteria

Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
Meet criteria for stage I or II hypertension
Currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria

Secondary hypertension
Are taking three or more antihypertensive agents
Have uncontrolled or poorly controlled diabetes mellitus type I or type II
Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
Participation in any investigational study within 30 days of Screening (Visit 1).
Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00770861). 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.