Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 3 | 7 |
| List of Tables | 5 | 2 |
| List of Figures | 7 | 3 |
| Endpoints - Clinical Trials In Cardiovascular Disorders - Overview | 10 | 2 |
| Introduction | 10 | 1 |
| Types of Endpoints | 10 | 1 |
| Primary Endpoints | 10 | 1 |
| Secondary Endpoints | 10 | 1 |
| GBI Research Report Guidance | 11 | 1 |
| Endpoints - Clinical Trials In Cardiovascular Disorders - Major Endpoints of Top Five Cardiovascular Disorders | 12 | 3 |
| Endpoints - Major Marketed Drugs of Top Five Cardiovascular Disorders and their Regulatory Approval | 12 | 1 |
| Atherosclerosis | 13 | 1 |
| Atrial Fibrillation | 13 | 1 |
| Dyslipidemia | 13 | 1 |
| Hypertension | 14 | 1 |
| Venous Thromboembolism | 14 | 1 |
| Endpoints - Clinical Trials In Cardiovascular Disorders - Marketed and Pipeline Product Assessment | 15 | 121 |
| Atherosclerosis | 15 | 2 |
| Primary Endpoints Used in Atherosclerosis Clinical Trials | 17 | 1 |
| Secondary Endpoints Used in Atherosclerosis Clinical Trials | 17 | 1 |
| Major Marketed Drugs - Safety and Efficacy Analysis | 17 | 1 |
| Crestor (Rosuvastatin Calcium) | 17 | 2 |
| Niaspan (Niacin) | 19 | 1 |
| Advicor (Lovastatin; Niacin) | 20 | 1 |
| Phase III Clinical Trial Analysis | 21 | 1 |
| Primary Endpoints of Phase III Completed Trials | 21 | 2 |
| Secondary Endpoints of Phase III Completed Trials | 23 | 2 |
| Primary Endpoints of Phase III Ongoing Trials | 25 | 1 |
| Secondary Endpoints of Phase III Ongoing Clinical Trials | 26 | 1 |
| Most Promising Drug s Profile | 27 | 1 |
| Darapladib | 27 | 1 |
| Anacetrapib | 28 | 1 |
| Dalcetrapib (RG1658, JTT-705, RO4607381) | 29 | 1 |
| Vorapaxar | 30 | 1 |
| Phase II Clinical Trial Analysis | 31 | 1 |
| Primary Endpoints of Phase II Completed Clinical Trials | 31 | 1 |
| Secondary Endpoints of Phase II Completed Clinical Trials | 32 | 2 |
| Primary Endpoints of Phase II Ongoing Clinical Trials | 34 | 1 |
| Secondary Endpoints of Phase II Ongoing Clinical Trials | 35 | 1 |
| Terminated Trials Analysis | 35 | 1 |
| Atrial Fibrillation | 36 | 1 |
| Primary Endpoints Used in Atrial Fibrillation | 37 | 1 |
| Secondary Endpoints Used in Atrial Fibrillation | 37 | 1 |
| Major Marketed Drugs - Safety and Efficacy Analysis | 38 | 1 |
| Multaq (dronedarone) | 38 | 1 |
| Tikosyn (dofetilide) | 39 | 1 |
| Tambocor (flecainide acetate) | 40 | 1 |
| Betapace AF | 41 | 1 |
| Pradaxa (dabigatran etexilate) | 42 | 1 |
| Phase III Clinical Trial Analysis | 43 | 1 |
| Primary Endpoints of Phase III Completed Trials | 43 | 2 |
| Secondary Endpoints of Phase III Completed Trials | 45 | 3 |
| Primary Endpoints of Phase III Ongoing Trials | 48 | 1 |
| Secondary Endpoints of Phase III Ongoing Trials | 49 | 2 |
| Most Promising Drug s Profile | 51 | 1 |
| Azimilide Dihydrochloride (stedicor) (Warner Chilcott/Blue Ash Therapeutics) | 51 | 1 |
| Vernakalant Oral (Merck/Cardiome Pharma) | 52 | 1 |
| Edoxaban | 53 | 1 |
| Phase II Clinical Trial Analysis | 54 | 1 |
| Primary Endpoints of Phase II Completed Clinical Trials | 54 | 2 |
| Secondary Endpoints of Phase II Completed Trials | 56 | 3 |
| Primary Endpoints of Phase II Ongoing Clinical Trials | 59 | 1 |
| Secondary Endpoints of Phase II Ongoing Trials | 59 | 1 |
| Terminated Trials Analysis | 60 | 1 |
| Dyslipidemia | 61 | 1 |
| Primary Endpoints Used in Dyslipidemia | 61 | 1 |
| Secondary Endpoints Used in Dyslipidemia | 62 | 1 |
| Major Marketed Drugs - Safety and Efficacy Analysis | 62 | 1 |
| Lipitor (atorvastatin calcium) | 62 | 1 |
| Crestor (Rosuvastatin Calcium) | 63 | 2 |
| Vyotrin (ezetimibe/simvastatin) | 65 | 1 |
| Trilipix (fenofibric acid) | 66 | 1 |
| Lescol (fluvastatin sodium) | 67 | 2 |
| Phase III Clinical Trial Analysis | 69 | 1 |
| Primary Endpoints of Phase III Completed Trials | 69 | 2 |
| Secondary Endpoints of Phase III Completed Trials | 71 | 3 |
| Primary Endpoints of Phase III Ongoing Trials | 74 | 1 |
| Secondary Endpoints of Phase III Ongoing Trials | 75 | 1 |
| Most Promising Drug s Profile | 76 | 1 |
| Cetriad (rosuvastatin/fenofibric acid, ABT-335) | 76 | 1 |
| ABT335 (SLV348, Trilipix) + simvastatin or atorvastatin | 77 | 1 |
| RG1658 (Dalcetrapib, JTT-705, RO4607381) | 78 | 1 |
| GFT505 | 79 | 2 |
| Phase II Clinical Trial Analysis | 81 | 1 |
| Primary Endpoints of Phase II Completed Clinical Trials | 81 | 2 |
| Secondary Endpoints of Phase II Completed Trials | 83 | 2 |
| Primary Endpoints of Phase II Ongoing Clinical Trials | 85 | 1 |
| Secondary Endpoints of Phase II Ongoing Trials | 86 | 1 |
| Terminated Trials Analysis | 87 | 1 |
| Hypertension | 88 | 1 |
| Primary Endpoints Used in Hypertension | 88 | 1 |
| Secondary Endpoints Used in Hypertension | 89 | 1 |
| Major Marketed Drugs - Safety and Efficacy Analysis | 89 | 1 |
| Diovan (valsartan) | 89 | 1 |
| Atacand | 90 | 1 |
| Avapro | 91 | 1 |
| Norvasc (amlodipine) | 92 | 1 |
| Micardis | 92 | 2 |
| Phase III Clinical Trial Analysis | 94 | 1 |
| Primary Endpoints of Phase III Completed Trials | 94 | 1 |
| Secondary Endpoints of Phase III Completed Trials | 95 | 10 |
| Primary Endpoints of Phase III Ongoing Trials | 105 | 1 |
| Secondary Endpoints of Phase III Ongoing Trials | 106 | 2 |
| Most Promising Drug s Profile | 108 | 1 |
| SPP635 | 108 | 1 |
| Actos (pioglitazone) | 109 | 1 |
| Phase II Clinical Trial Analysis | 110 | 1 |
| Primary Endpoints of Phase II Completed Clinical Trials | 110 | 2 |
| Secondary Endpoints of Phase II Completed Trials | 112 | 3 |
| Primary Endpoints of Phase II Ongoing Clinical Trials | 115 | 1 |
| Secondary Endpoints of Phase II Ongoing Trials | 116 | 1 |
| Terminated Trials Analysis | 117 | 1 |
| Venous Thromboembolism | 118 | 1 |
| Primary Endpoints Used in Venous Thromboembolism | 118 | 1 |
| Secondary Endpoints Used in Venous Thromboembolism | 119 | 1 |
| Major Marketed Drugs - Safety and Efficacy Analysis | 119 | 1 |
| Enoxaparin (Lovenox or Clexane) | 119 | 1 |
| Dalteparin (Fragmin) | 120 | 1 |
| Xarelto (Rivaroxaban) | 121 | 1 |
| Phase III Clinical Trial Analysis | 122 | 1 |
| Primary Endpoints of Phase III Completed Trials | 122 | 2 |
| Secondary Endpoints of Phase III Completed Trials | 124 | 3 |
| Primary Endpoints of Phase III Ongoing Trials | 127 | 1 |
| Secondary Endpoints of Phase III Ongoing Trials | 128 | 1 |
| Most Promising Drug s Profile | 129 | 1 |
| YM150 | 129 | 1 |
| Eliquis (Apixaban) | 130 | 1 |
| Phase II Clinical Trial Analysis | 131 | 1 |
| Primary Endpoints of Phase II Completed Clinical Trials | 131 | 1 |
| Secondary Endpoints of Phase II Completed Trials | 132 | 2 |
| Primary Endpoints of Phase II Ongoing Trials | 134 | 1 |
| Secondary Endpoints of Phase II Ongoing Trials | 134 | 1 |
| Terminated Trials Analysis | 135 | 1 |
| Endpoints - Clinical Trials In Cardiovascular Disorders - Competitive Landscape | 136 | 12 |
| Pfizer Inc. | 136 | 1 |
| Company Overview | 136 | 1 |
| Major Cardiovascular Drugs Marketed by Pfizer | 136 | 2 |
| Sanofi S.A. | 138 | 1 |
| Company Overview | 138 | 1 |
| Major Cardiovascular Drugs Marketed by Sanofi S.A. | 138 | 1 |
| Novartis AG | 139 | 1 |
| Company Overview | 139 | 1 |
| Major Cardiovascular Drugs Marketed by Novartis AG | 139 | 2 |
| AstraZeneca PLC | 141 | 1 |
| Company Overview | 141 | 1 |
| Major Cardiovascular Drugs Marketed by AstraZeneca PLC | 141 | 1 |
| Boehringer Ingelheim GmbH | 142 | 1 |
| Company Overview | 142 | 1 |
| Major Cardiovascular Drugs Marketed by Boehringer Ingelheim GmbH | 142 | 1 |
| Actelion Ltd. | 143 | 1 |
| Company Overview | 143 | 1 |
| Major Cardiovascular Drugs Marketed by Actelion Ltd. | 143 | 1 |
| Daiichi Sankyo Company Ltd. | 144 | 1 |
| Company Overview | 144 | 1 |
| Major Cardiovascular Drugs Marketed by Daiichi Sankyo Company Ltd. | 144 | 1 |
| Abbott Laboratories | 145 | 1 |
| Company Overview | 145 | 1 |
| Major Cardiovascular Drugs Marketed by Abbott Laboratories | 145 | 1 |
| Bayer AG | 146 | 1 |
| Company Overview | 146 | 1 |
| Major Cardiovascular Drugs Marketed by Bayer AG | 146 | 1 |
| GlaxoSmithKline PLC | 147 | 1 |
| Company Overview | 147 | 1 |
| Major Cardiovascular Drugs Marketed by GlaxoSmithKline PLC | 147 | 1 |
| Endpoints - Clinical Trials In Cardiovascular Disorders - Appendix | 148 | 5 |
| Market Definitions | 148 | 1 |
| Abbreviations | 148 | 1 |
| Research Methodology | 149 | 3 |
| Coverage | 149 | 1 |
| Secondary Research | 150 | 1 |
| Primary Research | 150 | 1 |
| Section Methodology | 150 | 1 |
| Clinical Trial Design Overview | 150 | 1 |
| Marketed and Pipeline Products Assessment | 151 | 1 |
| Company Profiles | 151 | 1 |
| Expert Panel Validation | 151 | 1 |
| Contact Us | 152 | 1 |
| Disclaimer | 152 | 1 |
| Sources | 152 | 1 |
