Safety Study of Nebivolol for COPD Patients

NCT01939990 | Withdrawn Phase 2

• 1 other identifier: 11-0720
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

High Blood Pressure

Keywords

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• to assess blood pressure control

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

  baseline to 4 weeks

Secondary Outcomes (1)

• to assess pulmonary function tests

  baseline to 4 weeks

Study Arms (2)

Nebivolol

ACTIVE COMPARATOR

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

Drug: Nebivolol

Placebo

PLACEBO COMPARATOR

Group B will be given Placebo.

Drug: Placebo

Interventions

Placebo DRUG

The placebo looks like the study drug but it does not contain active ingredients.

Also known as: Placebo is a sugar pill.

Placebo

Nebivolol DRUG

5 to 10mg per day

Also known as: bystolic

Nebivolol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Links

• clinical trials at the University of Chicago

MeSH Terms

Conditions

Hypertension; Pulmonary Disease, Chronic Obstructive

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• George Bakris, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: September 11, 2013
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)