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BRAVE Study With Uncontrolled Essential Hypertension (BRAVE Study)

NCT02398929 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-06

No results posted yet for this study

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 After informed consent is obtained, subjects will be withdrawn from previous antihypertensive therapy and given placebo for at least 2 weeks.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.

Conditions

Interventions

DRUG

Bisoprolol 2.5 mg

Bisoprolol 2.5 mg will be given once daily

DRUG

Placebo

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Brian Tomlinson, MD · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2021-01-05
Completion
2021-01-05

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398929 on ClinicalTrials.gov