NCT01939990WithdrawnPhase 2
Nebivolol in Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- University of Chicago
- Locations
- 1
- Primary Endpoint
- to assess blood pressure control
Study Overview
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD).
Detailed Description
The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD)
Exclusion Criteria
- •Asthma; Heart failur;
- •End stage kidney disease;
- •acute myocardial infarction,unstable angina, stroke or TIA within the past year;
- •Females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.
Arms & Interventions
Nebivolol
Active Comparator
Group A will be given Nebivolol 5 to 10mg per day
Intervention: Nebivolol (Drug)
Placebo
Placebo Comparator
Group B will be given Placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
to assess blood pressure control
Time Frame: baseline to 4 weeks
blood pressure control will be assessed per collection of research data at protocol visits.
Secondary Outcomes
- to assess pulmonary function tests(baseline to 4 weeks)
Investigators
Study Sites (1)
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