Safety and Effects of Ramipril Combined With Candesartan | NCT00356395

Studies
Safety and Effects of Ramipril Combined With Candesartan

NCT00356395

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Jul 26, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Hypertension

Interventions

ramipril, candesartan

Countries

Not provided

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 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Jul 25, 2006

First Submission Date that Met QC Criteria

Jul 25, 2006

First Posted Date

Jul 26, 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

Jul 25, 2006

Last Update Posted Date

Jul 26, 2006Estimated

Description Module

Brief Summary

we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.

Detailed Description

Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).

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, candesartan	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
comparison of endothelium-dependent dilation among the 3 treatment schemes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with mild to moderate hypertension

Exclusion Criteria:

We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kwang K Koh, MD	Cardiology, Gil Heart Center, Gachon Medical School	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017257	Ramipril
C081643	candesartan

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