Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

March 8, 2007 updated by: Pacific Pharmaceuticals

Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension

The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

86

Phase

  • Phase 4

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
    • 28 Yeongeon-dong, Jongno-gu
      • Seoul, 28 Yeongeon-dong, Jongno-gu, Korea, Republic of, 110-744
        • Seoul National University 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)

Exclusion Criteria:

  • 180mmHg≤SBP
  • If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings
  • If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings
  • impaired hepatic function
  • imapaired renal function
  • angioedema
  • aortic valvular stenosis or obstrcutive ejection disorder
  • primary hyperaldosteronism
  • renal transplantation, bilateral renal artery stenosis or unilateral stenosis in a single kidney, hemodialysis
  • severe respiratory disease
  • congestive heart failure( New York Association functional class Ⅲ or Ⅳ)
  • malignant hypertension
  • labile angina pectoris or myocardial infarction in the last 3 months before study entry

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of DBP(diastolic blood pressure)

Secondary Outcome Measures

Outcome Measure
Reduction of SBP(systolic blood pressure)
Percentage of patients with Dcrease of BP(blood pressure)
Percentage of patients with a Normalization of BP(blood pressure)
Artery stiffness(chang of pulse wave velocity)
Left ventricular diastolic function
Change of BNP
Change of CRP

Collaborators and Investigators

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

Sponsor

Pacific Pharmaceuticals

Investigators

  • Principal Investigator: HyoSoo Kim, Ph.D in MD, Seoul National University 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

June 1, 2006

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

March 9, 2007

Last Update Submitted That Met QC Criteria

March 8, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMN-P01

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.

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