Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: OJP-2028

• Registration Number: NCT00553865
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-03
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2014-09
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Adult men and women (Age 18-75 years)
2. Uncomplicated essential hypertension: Clinic sitting SiDBP between 90 and 109 mmHg after 2 week placebo run-in period

Exclusion Criteria

1. Secondary hypertension
2. History and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina)
3. Pregnancy or lactation
4. Contraindications to the antihypertensive drugs to be used during the treatment period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	OJP-2028	OJP-2028 2mg/day
Group 3	OJP-2028	OJP-2028 4mg/day
Group 4	OJP-2028	Placebo
Group 1	OJP-2028	OJP-2028 1mg/day
Group 5	OJP-2028	Reference drug

Primary Outcome Measures

Name	Time	Method
Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of