ILLUSTRATE Trial: Difference between revisions

Jump to navigation Jump to search
No edit summary
No edit summary
 
(4 intermediate revisions by 2 users not shown)
Line 3: Line 3:


{{CMG}}
{{CMG}}
==Overview==
 
'''Click [[media:ILLUSTRATE_Trial.ppt|here]] to download slides for ILLUSTRATE Trial.'''
==Official Title==
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease
==Objective==
*The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
*To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease
==Sponsor==
Pfizer
==Timeline==
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
|-
| Style="width:30%"| '''Start Date'''||Style="width:70%"| October 2003
|-
| '''End Date'''||September 2006
|-
| '''Status'''||Completed
|-
|}
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00134173.</span>
 
==Study Description==
 
{| class="wikitable" border="1" style="background:WhiteSmoke" width="40%"
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
|-
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional
|-
| '''Study Phase''' ||Phase 3
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
|-
| '''Allocation'''||Randomized
|-
| '''Endpoint'''||Safety/Efficacy Study
|-
| '''Interventional Model'''||Parallel Assignment
|-
| '''Masking'''||Double-Blind
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
|-
| '''Primary Purpose'''||Treatment
|-
| '''Condition'''||Coronary Disease<br>Coronary Arteriosclerosis<br>Hyperlipidemia
|-
| '''Intervention'''||Drug: torcetrapib/atorvastatin<br>Drug: atorvastatin
|-
| '''Study Arms'''||Not provided
|-
| '''Population Size'''||1100
|-
|}
 
<span style="font-size:85%">The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00134173.</span>
 
==Eligibility Criteria==
===Inclusion Criteria===
*Angiographic evidence of coronary atherosclerosis
===Exclusion Criteria===
*Women who are pregnant or lactating, or planning to become pregnant.
*Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known :lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid.
*Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
*Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely :that the subject would complete the study.
 
==Outcomes==
===Primary Outcomes===
Change coronary artery atheroma volume as measured by intravascular ultrasound.
===Secondary Outcomes===
Changes in levels of lipids and other biomarkers.
==Publications==
===Results===
 
===Conclusion===
 


==References==
==References==
Line 9: Line 86:


{{Lipopedia}}
{{Lipopedia}}
[[Category:Lipopedia]]
[[Category:Lipopedia]]
[[Category:HDL]]
[[Category:HDL]]
[[Category:Clinical trials]]
[[Category:Clinical trials]]
[[Category:HDLpedia]]

Latest revision as of 14:33, 21 October 2013

High Density Lipoprotein Microchapters

Home

Patient information

Overview

Historical Perspective

Classification

Physiology

Pathophysiology

Causes

Low HDL
High HDL

Epidemiology and Demographics

Screening

Natural History, Complications and Prognosis

Diagnosis

HDL Laboratory Test

Treatment

Medical Therapy

Prevention

Future or Investigational Therapies

Clinical Trials

Landmark Trials

List of All Trials

Case Studies

Case #1

ILLUSTRATE Trial On the Web

Most recent articles

Most cited articles

Review articles

CME Programs

Powerpoint slides

Images

American Roentgen Ray Society Images of ILLUSTRATE Trial

All Images
X-rays
Echo & Ultrasound
CT Images
MRI

Ongoing Trials at Clinical Trials.gov

US National Guidelines Clearinghouse

NICE Guidance

FDA on ILLUSTRATE Trial

CDC on ILLUSTRATE Trial

ILLUSTRATE Trial in the news

Blogs on ILLUSTRATE Trial

Directions to Hospitals Treating High density lipoprotein

Risk calculators and risk factors for ILLUSTRATE Trial

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Click here to download slides for ILLUSTRATE Trial.

Official Title

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease

Objective

  • The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
  • To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

Pfizer

Timeline

Timeline
Start Date October 2003
End Date September 2006
Status Completed

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00134173.

Study Description

Study Description
Study Type Interventional
Study Phase Phase 3
Study Design
Allocation Randomized
Endpoint Safety/Efficacy Study
Interventional Model Parallel Assignment
Masking Double-Blind
Study Details
Primary Purpose Treatment
Condition Coronary Disease
Coronary Arteriosclerosis
Hyperlipidemia
Intervention Drug: torcetrapib/atorvastatin
Drug: atorvastatin
Study Arms Not provided
Population Size 1100

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT00134173.

Eligibility Criteria

Inclusion Criteria

  • Angiographic evidence of coronary atherosclerosis

Exclusion Criteria

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known :lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely :that the subject would complete the study.

Outcomes

Primary Outcomes

Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Outcomes

Changes in levels of lipids and other biomarkers.

Publications

Results

Conclusion

References