A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function

NCT01522950 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CV-2014-20226
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled study comparing the efficacy of nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular disease risk in subjects with early vascular disease. Approximately 75 subjects with borderline/elevated blood pressures and impaired endothelial function, as measured by arterial elasticity scores, will be recruited and assigned to treatment groups using a block randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo, and then followed for 9 months.

Conditions

Hypertension

Keywords

hypertension; prevention; endothelial function

Outcome Measures

Primary Outcomes (1)

• Change in Small Artery Elasticity

  Change in small artery elasticity (a marker for endothelial function) from baseline to 9 months after intervention initiation.

  baseline, 9 months

Secondary Outcomes (3)

• Change in Large Artery Elasticity

  baseline, 9 months

• Change in Systolic Blood Pressure

  baseline, 9 months

• Change in Diastolic Blood Pressure

  baseline, 9 months

Study Arms (3)

Nebivolol

ACTIVE COMPARATOR

5 mg, continue for 1 month; dose titration to 10 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.

Drug: Nebivolol

Atenolol

ACTIVE COMPARATOR

25 mg, continue for 1 month; dose titration to 50 mg, continue for 8 months. Dose may be returned to initiation levels if side effects occur.

Drug: atenolol

Placebo

PLACEBO COMPARATOR

Continue for 1 month; dose titration to "high dose" placebo, continue for 8 months. Dose may be returned to initiation levels if side effects occur.

Drug: placebo

Interventions

Nebivolol DRUG

5 mg daily or 10 mg daily

Nebivolol

atenolol DRUG

25 mg daily or 50 mg daily

Atenolol

placebo DRUG

one tablet daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• borderline blood pressure (120-145/80-90 mm Hg);
• borderline or abnormal small artery elasticity (C2) as measured by pulse contour analysis;
• treatment-naive for all blood pressure medications including diuretics for at least 30 days prior to baseline visit;
• able to walk on a treadmill for 3 minutes;
• female patients with reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device during and for 1 month after the last dose of study drug;
• voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

You may not qualify if:

• history of intolerance to beta-blockers or clear contraindications to their use; current pharmaceutical treatment of blood pressure;
• known history of cardiovascular disease (myocardial infarction, coronary artery bypass graft, unstable angina, uncontrolled arrhythmias, stroke, etc.);
• known history of diabetes; known history of hepatic, renal or gastrointestinal disorder;
• known history of any illness that may cause additional risk (as determined by study investigator);
• pregnant or lactating women \[when used during pregnancy, beta-blockers may cause fetal harm\];
• participation in a concomitant clinical trial.

Sponsors & Collaborators

• University of Minnesota: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Duprez DA, Florea N, Duval S, Koukol C, Cohn JN. Effect of nebivolol or atenolol vs. placebo on cardiovascular health in subjects with borderline blood pressure: the EVIDENCE study. J Hum Hypertens. 2017 Dec;32(1):20-25. doi: 10.1038/s41371-017-0019-9. Epub 2017 Nov 28.

  PMID: 29184167 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Atenolol

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; Phenoxypropanolamines; Propanolamines; Propanols

Results Point of Contact

• Title: Jay N. Cohn, M.D., Professor of Medicine
• Organization: University of Minnesota

cohnx001@umn.edu

612.625.5646

Study Officials

• Jay N Cohn, MD

  University of Minnesota Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: February 1, 2012
• Study Start: May 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 17, 2020
• Results First Posted: January 21, 2020

Record last verified: 2020-07

Locations

US (1)