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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00553865

Enrollment

120

Registered

2007-11-06

Start date

2007-11-30

Completion date

2008-11-30

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

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.

Interventions

DRUGOJP-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026