NCT01634295

Efficacy and Safety of CKD-828 to Stage 2 Hypertension

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (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 two dose combination of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Detailed description

* In patients with Stage 2 hypertension to determine the efficacy and safety of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 10 weeks. * This study is consist of placebo run-in period(2 weeks\_single blind) and treatment period(10 weeks\_double blind.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	CKD-828 2.5/40mg	* Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.
DRUG	CKD-828 5/40mg	* Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.
DRUG	CKD-828 5/80mg	* Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks. * With the others investigation product placebo 4 tabs QD 6 weeks.
DRUG	S-amlodipine 2.5mg	* S-amlodipine 2.5mg QD 4 weeks * With the others investigation product placebo 4 tabs QD 4 weeks.
DRUG	S-amlodipine 5mg	* S-amlodipine 2.5mg QD 6weeks * With the others investigation product placebo 4 tabs QD 6 weeks.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-07-06
• Last updated: 2013-06-21

Locations

1 site across 1 country: South Korea