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

First Received on August 17, 2006. Last Updated on March 8, 2007 History of Changes

Sponsor:	Pacific Pharmaceuticals
Information provided by:	Pacific Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00366119

Purpose

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

Condition	Intervention	Phase
Essential Hypertension	Drug: Ramipril	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Ramipril

U.S. FDA Resources

Further study details as provided by Pacific Pharmaceuticals:

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

Estimated Enrollment:	86
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366119

Locations

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

Sponsors and Collaborators

Pacific Pharmaceuticals

Investigators

Principal Investigator:

HyoSoo Kim, Ph.D in MD

Seoul National University Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00366119 History of Changes
Other Study ID Numbers:	RMN-P01
Study First Received:	August 17, 2006
Last Updated:	March 8, 2007
Health Authority:	Korea: Institutional Review Board

Keywords provided by Pacific Pharmaceuticals:

hypertension
ramipril
blood pressure

artery stiffness
BNP
CRP

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Ramipril
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012