Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

This study is ongoing, but not recruiting participants.

First Received: August 17, 2006 Last Updated: 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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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, 28 Yeongeon-dong, Jongno-gu
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

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

Keywords provided by Pacific Pharmaceuticals:

hypertension
ramipril
blood pressure

artery stiffness
BNP
CRP

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ramipril
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009