Efficacy and Safety of TELMINUVO to Stage 2 Hypertension
NCT01983735 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2013-11-14
Summary
The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.
Conditions
Interventions
- DRUG
-
TELMINUVO Tab. (80/2.5mg)
* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks. * With the others investigation product placebo 1 tab QD 2 weeks.
- DRUG
-
TELMINUVO Tab. (80/5mg)
* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks. * With the others investigation product placebo 1 tab QD 6 weeks.
- DRUG
-
S-amlodipine 2.5mg
* S-amlodipine 2.5mg QD 2 weeks * With the others investigation product placebo 1 tab QD 2 weeks.
- DRUG
-
S-amlodipine 5mg
* S-amlodipine 5mg QD 6weeks * With the others investigation product placebo 1 tab QD 6 weeks.
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-08-31
- Completion
- 2014-08-31
Countries
- South Korea
Study Locations
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