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This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.
This was a phase III open label clinical trial to evaluate the long-term efficacy and safety of lomitapide at the maximum tolerated dose (for each patient) established during the clinical trial 733-005/UP1002. Subjects completing the 78-week treatment period in study 733-005/UP1002 who have not met any of the stopping criteria will be eligible to participate in 733-012. The treatment period continued until a decision was made by the local competent authority regarding marketing authorization. Lomitapide will be given orally once daily. Patient specific doses will be carried forward from 733-005/UP1002, but will not exceed the maximum tolerated dose the patient received during 733-005 /UP1002. The maximum dose for any patient was 80 mg/day. There was no reference therapy in this trial. The effects of the study drug were compared to baseline data (from 733-005/UP1002). Concomitant lipid-lowering therapy including plasmapheresis or LDL apheresis is permitted.
Note that hereafter, Week 0 in Study 733-005/UP1002 will be referred to as Baseline and Week 48 in Study AEGR-733-012 will be referred to as Week 126 (of overall treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lomitapide | Experimental | Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lomitapide | Drug | 5-60 mg po every day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Cuchel, MD, PhD | University of Pennsylvania | Principal Investigator |
| Mark Sumeray, MD | Aegerion Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17215532 | Background | Cuchel M, Bloedon LT, Szapary PO, Kolansky DM, Wolfe ML, Sarkis A, Millar JS, Ikewaki K, Siegelman ES, Gregg RE, Rader DJ. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007 Jan 11;356(2):148-56. doi: 10.1056/NEJMoa061189. | |
| Background | Cuchel M, Meagher E, Marais AD, et.al. Abstract 1077: A phase III study of microsomal triglyceride transfer protein inhibitor lomitapide (AEGR-733) in patients with homozygous familial hypercholesterolemia: interim results at 6 months. Circulation, Nov 2009; 120: S441 | ||
| 36520008 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lomitapide | Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis. lomitapide: 5-60 mg po every day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline from initiation of treatment in Study 733-005/UP1002 (Safety Population)
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| ID | Title | Description |
|---|---|---|
| BG000 | Lomitapide | Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis. lomitapide: 5-60 mg po every day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
Week 78 of Study 733-005/UP1002 to Week 294 of Study 733-005/UP1002 (Week 216 of Study AEGR-733-012)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lomitapide | Maximum tolerated dose of lomitapide (up to 80mg/day) in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis. lomitapide: 5-60 mg po every day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Long, MD - VP Clinical | Aegerion Pharmaceuticals, Inc. | 857-242-5142 | alison.long@aegerion.com |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D006937 | Hypercholesterolemia |
| D000090542 | Homozygous Familial Hypercholesterolemia |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C473731 | BMS201038 |
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Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). |
| Baseline and Week 222 |
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Baseline and Week 126 |
| Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Baseline and Week 174 |
| Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Baseline and Week 222 |
| Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Baseline and Week 246 |
| Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Baseline and Week 270 |
| Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Baseline and Week 294 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Robarts Research Institute | London | Ontario | N6A 5K8 | Canada |
| Lipid Clinic and University of Montreal Community Genomic Medicine Center | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Medicina Interna Universitaria | Ferrara | Sicily | Italy |
| Dipartimento di Medicina Clinica e Delle Patologie Emergenti | Palermo | Sicily | Italy |
| Centro Universitario Dislipidemie | Milan | Italy |
| DAI Ematologia, Oncologia, Anatomia Patologica e Medicina | Roma | Italy |
| Cardiology Research | Bloemfontein | 9300 | South Africa |
| University of Capetown | Cape Town | 7925 | South Africa |
| Derived |
| Larrey D, D'Erasmo L, O'Brien S, Arca M; Italian Working Group on Lomitapide. Long-term hepatic safety of lomitapide in homozygous familial hypercholesterolaemia. Liver Int. 2023 Feb;43(2):413-423. doi: 10.1111/liv.15497. Epub 2022 Dec 30. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) | Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Total Cholesterol | Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B (Apo B) | Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Triglycerides | Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) | Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) | Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Lp(a) | Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in High Density Lipoprotein Cholesterol (HDL-C) | Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| Secondary | Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012). | Week 126 Completers Population | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 126 |
|
|
|
| Secondary | Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 174 |
|
|
|
| Secondary | Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 222 |
|
|
|
| Secondary | Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 246 |
|
|
|
| Secondary | Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 270 |
|
|
|
| Secondary | Percent Change in Apolipoprotein AI (Apo AI) | Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012). | Safety Population - The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 294 |
|
|
|
| 1 |
| 19 |
| 7 |
| 19 |
| 17 |
| 19 |
| Aortic Value Incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Reflux Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sudden Cardiac Death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| International Normalized Ratio Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhabdomyolsis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Facial Palsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anticoagulant Therapy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Arteriovenous Fistula | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Aortic Valve Incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chapped Lips | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epigastric Discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Intestinal Mass | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Reflux Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vestibulitis | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Gastrointestinal Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitus | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Post Procedural Diarrhoea | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Procedural Headache | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Skeletal Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Asparate Aminotransferase Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatine phosphokinase Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Carotene Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Carotid Bruit | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| International Normalized Ratio Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| International Normalized Ratio Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Prothrombin Time Prolonged | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Vitamin K Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Oral Intake Reduced | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vitamin E Deficiency | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Facial Palsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sensory Disturbance | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Painful Respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Anticoagulant Therapy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Arterial Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arteriovenous Fistula | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sudden Cardiac Death | General disorders | MedDRA 11.0 | Systematic Assessment |
|
The CTAs generally envision a multisite publication, with the PI's right to publish individually if the pooled publication does not occur within 12 months of study completion. Sponsor has a 45 to 60 day review/approval period to request deletion of confidential information or to request limited deferral to protect its proprietary technology. In one case, the publication provision is more general, specifying that the Sponsor and clinical site will agree on the manner/terms of publication.
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |