Long Term Safety Study of PRALUENT

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Heterozygous Familial Hypercholesterolemia; Non-familial Hypercholesterolemia

Treatments: Drug: Praluent

Study type: Interventional

Funder types: Industry

Identifiers

NCT03694197

2018-002810-11 (EudraCT Number)

R727-CL-1609

Details and patient eligibility

About

The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682).

The secondary objectives of the study were:

• To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)
• To evaluate the effect of PRALUENT on other lipid parameters
• To evaluate the effect of PRALUENT on gonadal steroid hormones

Enrollment: 1,389 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Key Exclusion Criteria:

1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
4. Known hypersensitivity to monoclonal antibody or any component of the drug product
5. Pregnant or breastfeeding women

Note: Other inclusion/ exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,389 participants in 1 patient group

Open label

Experimental group

Treatment:

Drug: Praluent