NCT00553865
Completed
Phase 2
A 8-Week, Randomized, Double-blind, Parallel Designed, Phase II Multi-center Clinical Trial to Evaluate the Antihypertensive Efficacy and the Safety of OJP-2028 Tablets in Patients With the Uncomplicated Essential Hypertension
Overview
- Phase
- Phase 2
- Intervention
- OJP-2028
- Conditions
- Essential Hypertension
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine the optimal dosage of the clinical trial which is evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.
Detailed Description
Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult men and women (Age 18-75 years)
- •Uncomplicated essential hypertension: Clinic sitting SiDBP between 90 and 109 mmHg after 2 week placebo run-in period
Exclusion Criteria
- •Secondary hypertension
- •History and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina)
- •Pregnancy or lactation
- •Contraindications to the antihypertensive drugs to be used during the treatment period
Arms & Interventions
Group 1
OJP-2028 1mg/day
Intervention: OJP-2028
Group 2
OJP-2028 2mg/day
Intervention: OJP-2028
Group 3
OJP-2028 4mg/day
Intervention: OJP-2028
Group 4
Placebo
Intervention: OJP-2028
Group 5
Reference drug
Intervention: OJP-2028
Outcomes
Primary Outcomes
Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
Time Frame: 8 weeks
Secondary Outcomes
- Average SiSBP Differences of each group by comparison with the baseline.(8 weeks)
- Responder rate of each group by comparison with the baseline.(8 weeks)
- Average SiDBP and SiSBP Differences of each group by comparison with the baseline.(8 weeks)
Study Sites (1)
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