History of Changes for Study: NCT02135705

LOWER: Lomitapide Observational Worldwide Evaluation Registry (LOWER)

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	May 8, 2014	None (earliest Version on record)
2	December 13, 2017	Study Status and Contacts/Locations
3	December 2, 2020	Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators, Study Identification, Eligibility and Outcome Measures
4	December 14, 2022	Contacts/Locations, Eligibility and Study Status
5	March 11, 2024	Contacts/Locations, Study Status and Eligibility

Comparison Format:

Study NCT02135705
Submitted Date: May 8, 2014 (v1)

Study Identification


Unique Protocol ID:	AEGR-733-025
Brief Title:	LOWER: Lomitapide Observational Worldwide Evaluation Registry (LOWER)
Official Title:	LOWER: Lomitapide Observational Worldwide Evaluation Registry
Secondary IDs:

Study Status


Record Verification:	May 2014
Overall Status:	Enrolling by invitation
Study Start:	March 2014
Primary Completion:	March 2028 [Anticipated]
Study Completion:	September 2028 [Anticipated]

First Submitted:	April 10, 2014
First Submitted that Met QC Criteria:	May 8, 2014
First Posted:	May 12, 2014 [Estimate]

Last Update Submitted that Met QC Criteria:	May 8, 2014
Last Update Posted:	May 12, 2014 [Estimate]

Sponsor/Collaborators


Sponsor:	Aegerion Pharmaceuticals, Inc.
Responsible Party:	Sponsor
Collaborators:

Study Description


Brief Summary:	This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
Detailed Description:	To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	300 [Anticipated]
Number of Groups/Cohorts	1
Target Follow-Up Duration:	10 Years

Groups and Interventions

Groups/Cohorts	Interventions
Lomitapide Lomitapide as prescribed by Physician.	Drug: Lomitapide As prescribed by Physician. Other Names: Juxtapid Lojuxta

Outcome Measures


Primary Outcome Measures:
1.	Hepatic Abnormalities [ Time Frame: patients will be followed for 10 years ] to evaluate the occurrence of hepatic abnormalities
Secondary Outcome Measures:
1.	Gastrointestinal (GI) Events [ Time Frame: patients will be followed for 10 years ] to evaluate the occurrence of GI events
2.	Tumors [ Time Frame: patients will be followed for 10 years ] to evaluate any occurrence of tumors (small bowel, hepatic, colorectal or pancreatic)
3.	Events associated with coagulopathy [ Time Frame: patients will be followed for 10 years ] to evaluate the occurrence of events associated with coagulopathy (abnormal bleeding, cerebral haemorrhage or GI bleeding)

Eligibility


Study Population:	Adult patients treated with lomitapide who agree to participate in the study.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Adult patients (age ≥18 years) who meet one of the following two criteria: Initiating treatment with lomitapide at the time of registry enrolment, or initiated treatment with lomitapide within 15 months prior to enrolment into the registry and after lomitapide commercial availability in the country. Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures. Exclusion Criteria: Patients who are receiving lomitapide in clinical trials Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received MA in the country of participation.

Contacts/Locations


Study Officials:	Helen Phillips, MD Principal Investigator Aegerion Pharmaceuticals, Inc.
Locations:	United States, Michigan
	Complete Family Care Sterling Heights, Michigan, United States, 48314