Safety and Efficacy of Ramipril in the Treatment of Essen... | NCT00366119

Studies
Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

NCT00366119

Sponsor

Pacific Pharmaceuticals

Status

Unknown status

Last Update Posted

Mar 9, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Essential Hypertension

Interventions

Ramipril

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007

First Submitted Date

Aug 17, 2006

First Submission Date that Met QC Criteria

Aug 17, 2006

First Posted Date

Aug 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2007

Last Update Posted Date

Mar 9, 2007Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ramipril	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of DBP(diastolic blood pressure)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HyoSoo Kim, Ph.D in MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	28 Yeongeon-dong, Jongno-gu	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017257	Ramipril

Ancestor Terms

ID	Term
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided