Safety Study of Nebivolol for COPD Patients

January 11, 2016 updated by: University of Chicago

Nebivolol in Chronic Obstructive Pulmonary Disease

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess pulmonary function tests
Time Frame: baseline to 4 weeks
pulmonary function tests will be assessed at protocol visits
baseline to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Forest Laboratories

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0720

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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