NCT03635125

Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine

A Prospective, Randomized, Open-Label, Active-Comparator, Blinded-Endpoint, 12-week Forced-Titration Study of the Efficacy and Safety of Nebivolol Verses Metoprolol in Hypertensive Subjects Taking Amlodipine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Trinity Hypertension & Metabolic Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.

Detailed description

Open-label, single center study consisting of a 2 to 4 week baseline washout phase, a 12-week Amlodipine background treatment phase followed by a 4-week Low Dose Nebivolol/Metoprolol Treatment phase and a 4-week High Dose Nebivolol/Metoprolol Treatment Phase.

Conditions

• JNC 7 Stage 1 or 2 Hypertension

Interventions

Type	Name	Description
DRUG	Nebivolol I	Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
DRUG	Nebivolol II	Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
OTHER	Baseline Washout Phase	2 to 4 week Baseline Washout Phase

Timeline

• Start date: 2010-08-30
• Primary completion: 2011-05-26
• Completion: 2011-07-18
• First posted: 2018-08-17
• Last updated: 2018-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study