NCT00547300

Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

Detailed description

This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Metoprolol ER	Metoprolol ER once daily, oral administration
DRUG	Nebivolol	Nebivolol once daily, oral administration

Timeline

• Start date: 2007-10-31
• Primary completion: 2008-01-02
• Completion: 2008-01-02
• First posted: 2007-10-22
• Last updated: 2019-05-21
• Results posted: 2019-05-21

Locations

24 sites across 1 country: United States