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24 Hour Ambulatory Cardiac Oxygen Consumption

NCT05170061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-06-08

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Summary

A randomized,double-blind, active controlled,15 week study to evaluate the effects of nebivolol and valsartan alone and in combination on 24-hour ambulatory cardiac work and variability of heart rate-mean central systolic pressure product.

Conditions

Interventions

DRUG

Nebivolol

Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)

DRUG

Valsartan

Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).

DRUG

Nebivolol/valsartan combination

Valsartan/Nebivolol, 160/20 mg daily (1 week) followed by valsartan/nebivolol 320/40 mg daily (3 weeks) followed by valsartan/nebivolol 160/20 mg daily (1 week)

Sponsors & Collaborators

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Joseph L Izzo, MD · SUNY Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05170061 on ClinicalTrials.gov