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Completed

NCT Number: NCT00553865

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OJP-2028

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.

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2007
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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