High Blood Pressure
Conditions
Keywords
Chronic Obstructive Pulmonary Disease
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.
Interventions
DRUGPlacebo
The placebo looks like the study drug but it does not contain active ingredients.
DRUGNebivolol
5 to 10mg per day
Sponsors
Forest Laboratories
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to assess blood pressure control | baseline to 4 weeks | blood pressure control will be assessed per collection of research data at protocol visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to assess pulmonary function tests | baseline to 4 weeks | pulmonary function tests will be assessed at protocol visits |
Countries
United States
Outcome results
None listed