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Safety Study of Nebivolol for COPD Patients

Sponsor
University of Chicago (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01939990
Collaborator
Forest Laboratories (Industry)
0
Enrollment
1
Location
2
Arms
14
Duration (Months)
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Health Services Research
Official Title:
Nebivolol in Chronic Obstructive Pulmonary Disease
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nebivolol

Group A will be given Nebivolol 5 to 10mg per day

Drug: Nebivolol
5 to 10mg per day
Other Names:
  • bystolic

    		•
    Placebo Comparator: Placebo

    Group B will be given Placebo.

    Drug: Placebo
    The placebo looks like the study drug but it does not contain active ingredients.
    Other Names:
  • Placebo is a sugar pill.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. to assess blood pressure control [baseline to 4 weeks]

      blood pressure control will be assessed per collection of research data at protocol visits.

    Secondary Outcome Measures

    1. to assess pulmonary function tests [baseline to 4 weeks]

      pulmonary function tests will be assessed at protocol visits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Medical Center Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago
    • Forest Laboratories

    Investigators

    • Principal Investigator: George Bakris, MD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT01939990
    Other Study ID Numbers:
    • 11-0720
    First Posted:
    Sep 11, 2013
    Last Update Posted:
    Jan 12, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by University of Chicago
    Chronic Obstructive Pulmonary Disease
    Additional relevant MeSH terms:
    Hypertension
    Nebivolol

    Study Results

    No Results Posted as of Jan 12, 2016