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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00553865
First received: November 3, 2007
Last updated: June 27, 2016
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average SiSBP Differences of each group by comparison with the baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Responder rate of each group by comparison with the baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Average SiDBP and SiSBP Differences of each group by comparison with the baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 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. Reference group(Group 5): Reference Drug/day for 8 weeks.
Experimental: Group 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. Reference group(Group 5): Reference Drug/day for 8 weeks.
Experimental: Group 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. Reference group(Group 5): Reference Drug/day for 8 weeks.
Placebo Comparator: Group 4
Placebo
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.
Group 5
Reference drug
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.

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553865

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: CHEOL HO KIM Seoul National University Bundang Hospital
  More Information

Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00553865     History of Changes
Other Study ID Numbers: OJP-2028-II 
Study First Received: November 3, 2007
Last Updated: June 27, 2016
Health Authority: Korea: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 21, 2016