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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OJP-2028
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Other

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

OJP-2028 1mg/day

OJP-2028 2mg/day

OJP-2028 4mg/day

Placebo

Reference drug

Outcomes

Primary Outcome Measures

Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.

Secondary Outcome Measures

Average SiSBP Differences of each group by comparison with the baseline.
Responder rate of each group by comparison with the baseline.
Average SiDBP and SiSBP Differences of each group by comparison with the baseline.

Full Information

First Posted
November 3, 2007
Last Updated
June 27, 2016
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00553865
Brief Title
Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
OJP-2028 1mg/day
Arm Title
Group 2
Arm Type
Experimental
Arm Description
OJP-2028 2mg/day
Arm Title
Group 3
Arm Type
Experimental
Arm Description
OJP-2028 4mg/day
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Group 5
Arm Type
Other
Arm Description
Reference drug
Intervention Type
Drug
Intervention Name(s)
OJP-2028
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Average SiSBP Differences of each group by comparison with the baseline.
Time Frame
8 weeks
Title
Responder rate of each group by comparison with the baseline.
Time Frame
8 weeks
Title
Average SiDBP and SiSBP Differences of each group by comparison with the baseline.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHEOL HO KIM
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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