NCT01756430

Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension

Detailed description

* In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks. * This study is consist of placebo run-in period(2\~4 weeks\_single blind) and treatment period(8 weeks\_double blind).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Carvedilol SR 32mg, QD	* Carvedilol SR 32mg QD for 4 weeks * With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
DRUG	Carvedilol SR 64mg, QD	* Carvedilol SR 64mg QD for 4 weeks * With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks.
DRUG	Carvedilol IR 25mg, QD	* Carvedilol IR 25mg QD for 4 weeks * With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks.
DRUG	Carvedilol IR 25mg, BID	* Carvedilol IR 25mg BID for 4 weeks * With the others investigation product placebo 2 capsules QD for 4 weeks.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-12-27
• Last updated: 2014-01-14

Locations

1 site across 1 country: South Korea