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

NCT ID: NCT00553865

Last Updated: 2016-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-11-30

Brief Summary

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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

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

Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

OJP-2028 1mg/day

Group Type EXPERIMENTAL

OJP-2028

Intervention Type DRUG

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 2

OJP-2028 2mg/day

Group Type EXPERIMENTAL

OJP-2028

Intervention Type DRUG

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 3

OJP-2028 4mg/day

Group Type EXPERIMENTAL

OJP-2028

Intervention Type DRUG

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 4

Placebo

Group Type PLACEBO_COMPARATOR

OJP-2028

Intervention Type DRUG

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

Group Type OTHER

OJP-2028

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CHEOL HO KIM

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OJP-2028-II

Identifier Type: -

Identifier Source: org_study_id

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