NCT00766688|TerminatedPhase 3

Study Stopped

AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy

Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AVE5530 When Added to Ongoing Stable Statin Therapy at High Doses in Patients With Severe Primary Hypercholesterolemia

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC10841EudraCT 2008-002849-23

Study Type

interventional

Target

643

Locations

13 countries

Sites

Timeline

RegisteredOct 2008

StartedOct 2008

CompletionJun 2009

Brief Summary

The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

643

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach

13 countries

13 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

October 1, 2008

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed

Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

October 3, 2008

Last Update Submit

April 15, 2016

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

Percent change from baseline in calculated LDL-C
At week 12

Secondary Outcomes (2)

Percent change from baseline in calculated LDL-C
At 6 months and 12 months
Percent change from baseline in Total-Cholesterol and Apo-B
At 12 weeks, 6 months and 12 months

Study Arms (3)

25 mg/day AVE5530

EXPERIMENTAL

Drug: AVE5530

50 mg/day AVE5530

EXPERIMENTAL

Drug: AVE5530

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AVE5530DRUG

* one tablet in the evening with dinner * in addition to high doses of statin treatment

25 mg/day AVE553050 mg/day AVE5530

PlaceboDRUG

* one tablet in the evening with dinner * in addition to high doses of statin treatment

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults with severe primary hypercholesterolemia and cholesterol levels not controlled on ongoing stable statin treatment at maximum doses.

You may not qualify if:

LDL-C levels \> 250 mg/dL (6.48 mmol/L) or \< 100 mg/dL (2.59 mmol/L)
Triglycerides \>350 mg/dL (3.95 mmol/L)
Conditions / situations such as:
Presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
Active liver disease
Recent history of congestive heart failure, of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
Pregnant or breast-feeding women,
Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.