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Safety Study of Nebivolol for COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01939990
Recruitment Status : Withdrawn (Funding was discontinued.)
First Posted : September 11, 2013
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Chicago

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
High Blood Pressure Drug: Placebo Drug: Nebivolol 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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 Name: 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 Name: Placebo is a sugar pill.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. to assess pulmonary function tests [ Time Frame: baseline to 4 weeks ]
    pulmonary function tests will be assessed at protocol visits



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939990


Locations
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United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Forest Laboratories
Investigators
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Principal Investigator: George Bakris, MD University of Chicago

Additional Information:
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01939990     History of Changes
Other Study ID Numbers: 11-0720
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by University of Chicago:
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs