Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Jeil Pharmaceutical Co., Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Jeil Pharmaceutical Co., Ltd.
Information provided by:
Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00553865
First received: November 3, 2007
Last updated: November 7, 2007
Last verified: November 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: OJP-2028 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Jeil Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline. [ Time Frame: 8 weeks ]
Secondary Outcome Measures:
- Average SiSBP Differences of each group by comparison with the baseline. [ Time Frame: 8 weeks ]
- Responder rate of each group by comparison with the baseline. [ Time Frame: 8 weeks ]
- Average SiDBP and SiSBP Differences of each group by comparison with the baseline. [ Time Frame: 8 weeks ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
OJP-2028 1mg/day
|
Drug: OJP-2028
Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo/day for 8 weeks. Other(Reference group): Reference Drug/day for 8 weeks.
Other Name: OJP-2028
|
|
Experimental: 2
OJP-2028 2mg/day
|
Drug: OJP-2028
Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo/day for 8 weeks. Other(Reference group): Reference Drug/day for 8 weeks.
Other Name: OJP-2028
|
|
Experimental: 3
OJP-2028 4mg/day
|
Drug: OJP-2028
Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo/day for 8 weeks. Other(Reference group): Reference Drug/day for 8 weeks.
Other Name: OJP-2028
|
| Placebo Comparator: 4 |
Drug: OJP-2028
Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo/day for 8 weeks. Other(Reference group): Reference Drug/day for 8 weeks.
Other Name: OJP-2028
|
|
5
Reference drug
|
Drug: OJP-2028
Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo/day for 8 weeks. Other(Reference group): Reference Drug/day for 8 weeks.
Other Name: OJP-2028
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553865
Contacts
| Contact: CHEOL HO KIM | 82-31-787-7001 | cheolkim@plaza.snu.ac.kr |
Locations
| Korea, Republic of | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of | |
| Principal Investigator: CHEOL HO KIM | |
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | CHEOL HO KIM | Seoul National University Bundang Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00553865 History of Changes |
| Other Study ID Numbers: | OJP-2028-II |
| Study First Received: | November 3, 2007 |
| Last Updated: | November 7, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013