Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ramipril

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring hypertension, ramipril, blood pressure, artery stiffness, BNP, CRP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Outcomes

Primary Outcome Measures

Reduction of DBP(diastolic blood pressure)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00366119

First Posted

August 17, 2006

Last Updated

March 8, 2007

Sponsor

Pacific Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00366119

Brief Title

Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pacific Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

hypertension, ramipril, blood pressure, artery stiffness, BNP, CRP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

86 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ramipril

Primary Outcome Measure Information:

Title

Reduction of DBP(diastolic blood pressure)

Secondary Outcome Measure Information:

Title

Reduction of SBP(systolic blood pressure)

Title

Percentage of patients with Dcrease of BP(blood pressure)

Title

Percentage of patients with a Normalization of BP(blood pressure)

Title

Artery stiffness(chang of pulse wave velocity)

Title

Left ventricular diastolic function

Title

Change of BNP

Title

Change of CRP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HyoSoo Kim, Ph.D in MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

State/Province

28 Yeongeon-dong, Jongno-gu

ZIP/Postal Code

110-744

Country

Korea, Republic of

Essential Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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