Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00366119
• Other study ID #: RMN-P01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 17, 2006
• Last updated: March 8, 2007
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: March 2007
• Source: Pacific Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ? or ?)

• malignant hypertension

• labile angina pectoris or myocardial infarction in the last 3 months before study entry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Ramipril

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	28 Yeongeon-dong, Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of DBP(diastolic blood pressure)
Secondary	Reduction of SBP(systolic blood pressure)
Secondary	Percentage of patients with Dcrease of BP(blood pressure)
Secondary	Percentage of patients with a Normalization of BP(blood pressure)
Secondary	Artery stiffness(chang of pulse wave velocity)
Secondary	Left ventricular diastolic function
Secondary	Change of BNP
Secondary	Change of CRP