Long Term Safety Study of PRALUENT

Conditions

• Heterozygous Familial Hypercholesterolemia
• Non-familial Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Praluent — DRUG
  Subcutaneous (SC) administration

Study Details

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

Key Dates

Start date

Sep 28, 2018

Status verified

May 2021

Primary completion

Apr 8, 2020

Completion

Apr 8, 2020

Study Design

Enrollment

1,389 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Open label

Primary Outcome Measure

Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks [ Time Frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks ]

Locations (57)

Find similar trials in Auburn, AL

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