CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17 enrolled
Drug / intervention
nebivolol +1 moredrug
Likely dose
nebivolol 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01499134
NCT01499134Phase 3Completed
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Effect of Nebivolol Compared With Metoprolol in Hypertensive Patients With Peripheral Arterial Disease

Thomas Jefferson University·interventional·Posted Dec 26, 2011·Updated Dec 17, 2014

In Brief

A Phase 3 clinical trial evaluating nebivolol and Metoprolol succinate for Peripheral Artery Disease and Hypertension. Completed, enrolled 17 participants across 1 site.

Detailed Summary

This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral artery disease, hypertension, and at least moderate risk for coronary artery disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Hypertension
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 26, 2011
Enrollment StartAug 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.5 years ago

Interventions

nebivololdrug

Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).

Metoprolol succinatedrug

Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).