Safety Study of Nebivolol for COPD Patients

High Blood Pressure Clinical Trial

Official title:

Nebivolol in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01939990
• Other study ID #: 11-0720
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 22, 2013
• Last updated: January 11, 2016
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Placebo
The placebo looks like the study drug but it does not contain active ingredients.
• Nebivolol
5 to 10mg per day

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess blood pressure control	blood pressure control will be assessed per collection of research data at protocol visits.	baseline to 4 weeks	Yes
Secondary	to assess pulmonary function tests	pulmonary function tests will be assessed at protocol visits	baseline to 4 weeks	Yes

External Links

•   clinical trials at the University of Chicago