Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-28 @ 9:20 AM
Study NCT ID:
NCT01634295
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of CKD-828 to Stage 2 Hypertension
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* This study is consist of placebo run-in period(2 weeks\_single blind) and treatment period(10 weeks\_double blind.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: