NCT01501253

CKD-828 S-Amlodipine Non-Responder Trial

Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) vs. S-Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by S-Amlodipine Monotherapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (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 amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.

Detailed description

* In patients with essential hypertension inadequately controlled by S-Amlodipine monotherapy to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg)during 8weeks. * Included S-Amlodipine run-in period(during 4 weeks\_single blind) and Treatment period(during 8 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
DRUG	CKD-828 2.5/80mg	Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg
DRUG	S-Amlodipine 2.5mg	S-Amlodipine 2.5mg monotherapy

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-12-29
• Last updated: 2012-11-14

Locations

1 site across 1 country: South Korea