NCT00366119

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 9, 2007

Status Verified

March 1, 2007

First QC Date

August 17, 2006

Last Update Submit

March 8, 2007

Conditions

Essential Hypertension

Keywords

hypertensionramiprilblood pressureartery stiffnessBNPCRP

Outcome Measures

Primary Outcomes (1)

  • Reduction of DBP(diastolic blood pressure)

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

RamiprilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)

You may not qualify if:

  • mmHg≤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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 28 Yeongeon-dong, Jongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • HyoSoo Kim, Ph.D in MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2007

Last Updated

March 9, 2007

Record last verified: 2007-03

Locations

KR(1)