Trial Outcomes & Findings for Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED) (NCT NCT00423488)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

93 participants

Primary outcome timeframe

6 weeks of treatment (from Baseline to Endpoint)

Results posted on

2022-02-09

Participant milestones
Measure	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.	Ezetimibe Placebo + Simvastatin 40 mg Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
Overall Study STARTED	42	51
Overall Study COMPLETED	37	50
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal
Measure	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.	Ezetimibe Placebo + Simvastatin 40 mg Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
Overall Study No evidence of study drug intake	2	1
Overall Study No post baseline data	3	0

Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

Baseline characteristics by cohort
Measure	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg n=42 Participants Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.	Ezetimibe Placebo + Simvastatin 40 mg n=51 Participants Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.	Total n=93 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 6.5 • n=5 Participants	63.9 years STANDARD_DEVIATION 6.1 • n=7 Participants	64.4 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	39 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment Italy	42 participants n=5 Participants	51 participants n=7 Participants	93 participants n=5 Participants

Timeframe: 6 weeks of treatment (from Baseline to Endpoint)

Population: Intent-to-treat population only.

Outcome measures
Measure	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg n=37 Participants Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.	Ezetimibe Placebo + Simvastatin 40 mg n=50 Participants Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment	-32.2 percentage change Standard Deviation 15.7	-20.8 percentage change Standard Deviation 20.1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg n=40 participants at risk Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.	Ezetimibe Placebo + Simvastatin 40 mg n=50 participants at risk Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
Injury, poisoning and procedural complications Upper Limb Fracture	2.5% 1/40 • Number of events 1 The ezetimibe 10 mg + simvastatin placebo + simvastatin 20 mg safety population is comprised of 40 subjects as there was no evidence of study drug intake for 2 of the 42 randomized. The ezetimibe placebo + simvastatin 40 mg safety population is comprised of 50 participants as there was no evidence of study drug intake for 1 of the 51 randomized.	0.00% 0/50 The ezetimibe 10 mg + simvastatin placebo + simvastatin 20 mg safety population is comprised of 40 subjects as there was no evidence of study drug intake for 2 of the 42 randomized. The ezetimibe placebo + simvastatin 40 mg safety population is comprised of 50 participants as there was no evidence of study drug intake for 1 of the 51 randomized.

Adverse event data not reported

Merck Sharp & Dohme Corp.

Principal investigator is a sponsor employee Investigator agrees not to publish or publicaly present results without prior written authorization from the sponsor, except than for the dispositions provided for in Ministerial Circular n.6 of 02 SEP 2002 and, particularly, disposition n.1a) The investigator further agrees to provide 30 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of material(including text for oral presentation) that report study results.
Publication restrictions are in place

Restriction type: OTHER