Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Pacific Pharmaceuticals.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Pacific Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00366119

First received: August 17, 2006

Last updated: March 8, 2007

Last verified: March 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2006

Last Updated Date

March 8, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Reduction of DBP(diastolic blood pressure)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00366119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Essential Hypertension

Intervention ^ICMJE

Drug: Ramipril

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00366119

Other Study ID Numbers ^ICMJE

RMN-P01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pacific Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

HyoSoo Kim, Ph.D in MD

Seoul National University Hospital

Information Provided By

Pacific Pharmaceuticals

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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