NCT00553865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 29, 2016

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

November 3, 2007

Last Update Submit

June 27, 2016

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (3)

  • Average SiSBP Differences of each group by comparison with the baseline.

    8 weeks

  • Responder rate of each group by comparison with the baseline.

    8 weeks

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

    8 weeks

Study Arms (5)

Group 1

EXPERIMENTAL

OJP-2028 1mg/day

Drug: OJP-2028

Group 2

EXPERIMENTAL

OJP-2028 2mg/day

Drug: OJP-2028

Group 3

EXPERIMENTAL

OJP-2028 4mg/day

Drug: OJP-2028

Group 4

PLACEBO COMPARATOR

Placebo

Drug: OJP-2028

Group 5

OTHER

Reference drug

Drug: OJP-2028

Interventions

OJP-2028DRUG

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 1Group 2Group 3Group 4Group 5

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • CHEOL HO KIM

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

June 29, 2016

Record last verified: 2014-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)