Efficacy and Safety of Pactimibe in Patients With Atheros... | NCT00185146

Studies
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

NCT00185146

Sponsor

Sankyo Pharma Gmbh

Status

Completed

Last Update Posted

Mar 28, 2007Estimated

Enrollment

200

Phase

Phase 2

Conditions

Atherosclerosis

Interventions

Pactimibe

Countries

Germany

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Not provided

Completion Date

Aug 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

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 27, 2007

Last Update Posted Date

Mar 28, 2007Estimated

Description Module

Brief Summary

The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Pactimibe	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of pactimibe versus placebo on the progression of atherosclerosis

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy)
Intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography
Negative pregnancy test for females

Exclusion Criteria:

Whole blood donation (greater than or equal to 450 ml) during the last three months before study start
Unstable angina, congestive heart failure or uncontrolled hypertension
Renal disease including nephrectomy and/or renal transplant
Hepatic disease or abnormal liver function parameters
Drug abuse or alcohol addiction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
P U Witte, MD, PhD, FFPM	IMFORM GmbH	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C509302	pactimibe

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided