An Advanced Echocardiographic Evaluation of Nebivolol

NCT01206439 | Terminated Phase 4 Results

• 1 other identifier: UC- 09-12-31-04
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Systolic and Diastolic Myocardial Function

  Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.

  Baseline to day 180

Secondary Outcomes (1)

• Exercise Tolerance

  Baseline to day 180.

Study Arms (1)

Nebivolol 5 or 10 mg, oral, daily

EXPERIMENTAL

Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.

Drug: nebivolol

Interventions

nebivolol DRUG

nebivolol 5 or 10 mg oral, daily

Also known as: Bystolic

Nebivolol 5 or 10 mg, oral, daily

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of hypertension
• Written informed consent before initiation of any study related procedure
• Baseline Blood pressure \> 140 systolic or \>90 diastolic if on no antihypertensive therapy.
• Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.

You may not qualify if:

• Physical limitations resulting in a limited ability to walk on treadmill for stress echo
• Intolerance to beta blockers
• On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
• Currently pregnant or breast feeding.
• LFT \> 3 X ULN
• HgA1C \> 7
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
• Unwilling to follow protocol or return for study related procedures.
• Any of the following conditions:
• Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction
• Any other medical condition that in the PI's opinion could affect myocardial function.
• Current ETOH or illicit drug abuse -

Sponsors & Collaborators

• Jack Rubinstein: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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

Results Point of Contact

• Title: Jack Rubinstein
• Organization: University of Cincinnati

rubinsjk@ucmail.uc.edu

513-558-3062

Study Officials

• Jack Rubinstein, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: September 21, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 15, 2018
• Results First Posted: November 25, 2015

Record last verified: 2018-02

Locations

US (1)