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

June 27, 2016 updated by: Jeil Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Average SiSBP Differences of each group by comparison with the baseline.
Time Frame: 8 weeks
8 weeks
Responder rate of each group by comparison with the baseline.
Time Frame: 8 weeks
8 weeks
Average SiDBP and SiSBP Differences of each group by comparison with the baseline.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: CHEOL HO KIM, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 3, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OJP-2028-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Essential Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe