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

Jeil Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: OJP-2028

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553865

OJP-2028-II

Details and patient eligibility

About

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.

Full description

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 5 patient groups, including a placebo group

Group 1

Experimental group

Description:

OJP-2028 1mg/day

Treatment:

Drug: OJP-2028

Group 2

Experimental group

Description:

OJP-2028 2mg/day

Treatment:

Drug: OJP-2028

Group 3

Experimental group

Description:

OJP-2028 4mg/day

Treatment:

Drug: OJP-2028

Group 4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: OJP-2028

Group 5

Other group

Description:

Reference drug

Treatment:

Drug: OJP-2028