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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00553865
Other study ID # OJP-2028-II
Secondary ID
Status Completed
Phase Phase 2
First received November 3, 2007
Last updated June 27, 2016
Start date November 2007
Est. completion date November 2008

Study information

Verified date September 2014
Source Jeil Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
OJP-2028
Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline. 8 weeks No
Secondary Average SiSBP Differences of each group by comparison with the baseline. 8 weeks No
Secondary Responder rate of each group by comparison with the baseline. 8 weeks No
Secondary Average SiDBP and SiSBP Differences of each group by comparison with the baseline. 8 weeks No
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