Safety Study of Nebivolol for COPD Patients | NCT01939990

Studies
Safety Study of Nebivolol for COPD Patients

NCT01939990

Sponsor

University of Chicago

Status

Withdrawn

Last Update Posted

Jan 12, 2016Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

High Blood Pressure

Interventions

Placebo
Nebivolol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding was discontinued.

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 22, 2013

First Submission Date that Met QC Criteria

Sep 10, 2013

First Posted Date

Sep 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	The placebo looks like the study drug but it does not contain active ingredients.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Bakris, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago Medical Center		Chicago	Illinois	60637	United States

Label	URL
clinical trials at the University of Chicago	View source

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068577	Nebivolol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided