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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT00943306
Date of registration:	21/07/2009
Prospective Registration:	Yes
Primary sponsor:	Aegerion Pharmaceuticals, Inc.
Public title:	Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
Scientific title:	A Phase III, Long Term, Open Label, Follow on Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor 'Lomitapide' (LOMITAPIDE) in Patients With Homozygous Familial Hypercholesterolemia
Date of first enrolment:	October 29, 2009
Target sample size:	19
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00943306
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Canada	Italy	South Africa	United States

Contacts

Name:	Mark Sumeray, MD
Address:
Telephone:
Email:
Affiliation:	Aegerion Pharmaceuticals, Inc.

Name:	Marina Cuchel, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Completed UP1002 or 733-005.

2. Willing and able to provide consent and comply with the requirements of the study
protocol.

Exclusion Criteria:

1. Met any of the stopping rules for study discontinuation at the final visit of study
UP1002 or 733-005.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Familial Hypercholesterolemia

Intervention(s)

Drug: lomitapide

Primary Outcome(s)

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week 126]

Secondary Outcome(s)

Percent Change in Apolipoprotein AI (Apo AI) [Time Frame: Baseline and Week 126]

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 222]

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week 174]

Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) [Time Frame: Baseline and Week 222]

Percent Change in Total Cholesterol [Time Frame: Baseline and Week 222]

Percent Change in Triglycerides [Time Frame: Baseline and Week 246]

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 174]

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week 222]

Percent Change in Apolipoprotein AI (Apo AI) [Time Frame: Baseline and Week 270]

Percent Change in Apolipoprotein AI (Apo AI) [Time Frame: Baseline and Week 294]

Percent Change in Apolipoprotein B (Apo B) [Time Frame: Baseline and Week 126]

Percent Change in Apolipoprotein B (Apo B) [Time Frame: Baseline and Week 246]

Percent Change in Lp(a) [Time Frame: Baseline and Week 222]

Percent Change in Total Cholesterol [Time Frame: Baseline and Week 174]

Percent Change in Lp(a) [Time Frame: Baseline and Week 246]

Percent Change in Lp(a) [Time Frame: Baseline and Week 270]

Percent Change in Apolipoprotein B (Apo B) [Time Frame: Baseline and Week 294]

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 270]

Percent Change in Total Cholesterol [Time Frame: Baseline and Week 246]

Percent Change in Triglycerides [Time Frame: Baseline and Week 222]

Percent Change in Apolipoprotein B (Apo B) [Time Frame: Baseline and Week 174]

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 126]

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week 246]

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week 270]

Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 174]

Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 246]

Percent Change in Apolipoprotein AI (Apo AI) [Time Frame: Baseline and Week 174]

Percent Change in Apolipoprotein B (Apo B) [Time Frame: Baseline and Week 270]

Percent Change in Apolipoprotein AI (Apo AI) [Time Frame: Baseline and Week 246]

Percent Change in Apolipoprotein B (Apo B) [Time Frame: Baseline and Week 222]

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 246]

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline and Week 294]

Percent Change in High Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline and Week 294]

Percent Change in Lp(a) [Time Frame: Baseline and Week 126]

Percent Change in Lp(a) [Time Frame: Baseline and Week 174]

Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 222]

Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) [Time Frame: Baseline and Week 174]

Percent Change in Triglycerides [Time Frame: Baseline and Week 174]

Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) [Time Frame: Baseline and Week 246]

Percent Change in Total Cholesterol [Time Frame: Baseline and Week 294]

Percent Change in Lp(a) [Time Frame: Baseline and Week 294]

Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) [Time Frame: Baseline and Week 270]

Percent Change in Total Cholesterol [Time Frame: Baseline and Week 126]

Percent Change in Total Cholesterol [Time Frame: Baseline and Week 270]

Percent Change in Triglycerides [Time Frame: Baseline and Week 270]

Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 126]

Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 294]

Percent Change in Apolipoprotein AI (Apo AI) [Time Frame: Baseline and Week 222]

Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) [Time Frame: Baseline and Week 126]

Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) [Time Frame: Baseline and Week 294]

Percent Change in Triglycerides [Time Frame: Baseline and Week 126]

Percent Change in Triglycerides [Time Frame: Baseline and Week 294]

Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline and Week 270]

Secondary ID(s)

AEGR-733-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	11/05/2018
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00943306

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