CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Bisoprolol 2.5 mg +1 moredrug
Likely dose
Bisoprolol 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02398929
NCT02398929Phase 4Completed

An Open Label, Pharmacogenetic Study of Bisoprolol Treatment in Patients With Uncontrolled Essential Hypertension (BRAVE)

Chinese University of Hong Kong·interventional·Posted Mar 26, 2015·Updated Jan 6, 2021

In Brief

A Phase 4 clinical trial evaluating Bisoprolol 2.5 mg and Placebo for Hypertension. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This is an open-label, placebo run-in study to investigate the genetic and biomedical predictors of blood pressure response to bisoprolol. After informed consent is obtained, subjects will be withdrawn from previous antihypertensive therapy and given placebo for at least 2 weeks. Compliance will be assessed using pill counting, and any subject will a compliance less than 80% during the placebo run-in period will be excluded from the study. Bisoprolol 2.5 mg will be given once daily for 6 weeks. At baseline and after 6 weeks on bisoprolol 2.5 mg the clinic sitting blood pressure, 24-hour ambulatory blood pressure (if the patient is willing to do this), clinical characteristics and biochemical profile will be measured. Central aortic blood pressure will be measured with the A-PULSE device at baseline and after 6 weeks treatment. After completing 6 weeks treatment with bisoprolol 2.5 mg daily, the patient will continue treatment with bisoprolol for a total of 24 weeks unless there is any adverse event that requires discontinuation of bisoprolol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesHong Kong
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2015
Enrollment StartJan 1, 2013
Primary CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 11.3 years ago

Interventions

Bisoprolol 2.5 mgdrug

Bisoprolol 2.5 mg will be given once daily

Placebodrug

Placebo tablets will be given once daily for 2 weeks during the run-in period.