ILLUSTRATE Trial: Difference between revisions

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VisualWikitext

Latest revision as of 14:33, 21 October 2013

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

Sponsor

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

@@ Line 3: / Line 3: @@
 {{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==
@@ Line 9: / Line 86: @@
 {{Lipopedia}}
 [[Category:Lipopedia]]
 [[Category:HDL]]
 [[Category:Clinical trials]]
+[[Category:HDLpedia]]

v t e Lipopedia
Basic Science	Cholesterol • Triglyceride Lipoprotein metabolism and transport Lipoprotein: Chylomicron • Chylomicron remnant • HDL • IDL • LDL • Lipoprotein(a) • VLDL • Lipoprotein-X Apolipoprotein: APOA (1, 2, 4, 5) • APOB ( Apolipoprotein B-48, Apolipoprotein B-100) • APOC (1, 2, 3, 4) • APOD • APOE • APOH • APOJ • APOL • APOM • Apo(a) Lipoprotein receptor: LDL receptor • Soluble low density lipoprotein receptor-related protein (sLRP) • Apolipoprotein E Receptor 2 • Scavenger receptor • Scavenger receptor A • Scavenger receptor B • VLDL receptor Lipoprotein enzymes: Lipoprotein lipase • Lipoprotein-associated phospholipase A2 (Lp-PLA2) • Cholesterylester transfer protein ( Acetyl-CoA C-acyltransferase, Lecithin-cholesterol acyltransferase) • Microsomal triglyceride transfer protein • ABCA1 Genes: Low density lipoprotein receptor gene family • Microsomal triglyceride transfer protein • ABCA1
Lipoprotein Disorders	Lipoprotein disorders Primary lipoprotein disorders: Familial hyperchylomicronemia (Type I) • Familial hypercholesterolemia (Type IIA) • Familial combined hyperlipidemia (Type IIB) • Dysbetalipoproteinemia (Type III) • Primary hypertriglyceridemia (Type IV) • Mixed hyperlipoproteinemia (Type V) Secondary lipoprotein disorders
Abnormal Laboratory Lipid Profile	Low chylomicron • Low chylomicron remnant • Low HDL • Low IDL • Low LDL • Low lipoprotein(a) • Low VLDL High chylomicron • High chylomicron remnant • High HDL • High IDL • High LDL • High Lipoprotein(a) • High VLDL