Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension
Information source: Pacific Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: Ramipril (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Pacific Pharmaceuticals Official(s) and/or principal investigator(s):
HyoSoo Kim, Ph.D in MD, Principal Investigator, Affiliation: Seoul National University Hospital
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
Clinical Details
Official title: Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Reduction of DBP(diastolic blood pressure)
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Seoul National University Hospital, Seoul, 28 Yeongeon-dong, Jongno-gu 110-744, Korea, Republic of
Additional Information
Starting date: June 2006
Ending date: June 2007
Last updated: March 8, 2007
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