Essential Hypertension Clinical Trial
Official title:
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
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Jeil Pharmaceutical Co., Ltd. |
Korea, Republic of,
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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