A Phase 2 Dose Selection Trial of Candesartan Cilexetil and Amlodipine Besylate to Treat Essential Hypertension
NCT02059616 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 384
Last updated 2014-04-30
Summary
The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.
Conditions
- Essential Hypertension
Interventions
- DRUG
-
Amlodipine 5mg
Daily oral administration for 8 weeks
- DRUG
-
Amlodipine 10mg
Daily oral administration for 8 weeks
- DRUG
-
Candesartan Cilexetil 8mg
Daily oral administration for 8 weeks
- DRUG
-
Candesartan cilexetil 16mg
Daily oral administration for 8 weeks
Sponsors & Collaborators
-
HK inno.N Corporation
lead INDUSTRY
Principal Investigators
-
Seung-Jea Tahk · Ajou University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2015-06-30
- Completion
- 2015-12-31
Countries
- South Korea
Study Locations
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