Back to resultsSafety Study of Nebivolol for COPD Patients
Primary Purpose
High Blood Pressure
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Nebivolol
Sponsored by
About this trial
This is an interventional health services research trial for High Blood Pressure focused on measuring Chronic Obstructive Pulmonary Disease
Eligibility Criteria
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.
Sites / Locations
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nebivolol
Placebo
Arm Description
Group A will be given Nebivolol 5 to 10mg per day
Group B will be given Placebo.
Outcomes
Primary Outcome Measures
to assess blood pressure control
blood pressure control will be assessed per collection of research data at protocol visits.
Secondary Outcome Measures
to assess pulmonary function tests
pulmonary function tests will be assessed at protocol visits
Full Information
NCT ID
NCT01939990
First Posted
January 22, 2013
Last Updated
January 11, 2016
Sponsor
University of Chicago
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01939990
Brief Title
Safety Study of Nebivolol for COPD Patients
Official Title
Nebivolol in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was discontinued.
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nebivolol
Arm Type
Active Comparator
Arm Description
Group A will be given Nebivolol 5 to 10mg per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group B will be given Placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo is a sugar pill.
Intervention Description
The placebo looks like the study drug but it does not contain active ingredients.
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Other Intervention Name(s)
bystolic
Intervention Description
5 to 10mg per day
Primary Outcome Measure Information:
Title
to assess blood pressure control
Description
blood pressure control will be assessed per collection of research data at protocol visits.
Time Frame
baseline to 4 weeks
Secondary Outcome Measure Information:
Title
to assess pulmonary function tests
Description
pulmonary function tests will be assessed at protocol visits
Time Frame
baseline to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Bakris, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Links:
URL
http://aura.uchicago.edu
Description
clinical trials at the University of Chicago
Learn more about this trial
Safety Study of Nebivolol for COPD Patients
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