Trial · NCT00941603

Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

NCT00941603, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2016-04-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675). Trials, record NCT00941603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00941603

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
NCT number: NCT00941603
Status: Completed
Phases: Phase 2
Enrollment: 619 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Primary Hypercholesterolemia, Mixed Hyperlipidemia
Interventions: SCH 900271 15mg, SCH 900271, SCH 900271, SCH 900271, SCH 900271, Placebo
First posted: 2009-07-17
Last updated: 2018-09-25
Results first posted: 2016-04-12

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Direct LDL-C at Week 8	Baseline and Week 8	The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
Secondary	Change From Baseline in Direct Non-HDL-C at Week 8	Baseline and Week 8	The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Direct LDL-C at Week 8	Baseline and Week 8	Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.	Percent change	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Direct Non-HDL-C at Week 8	Baseline and Week 8	Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.	Percent change	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Direct LDL-C at Week 8	SCH 900271 15 mg	-2.0	Standard Error 1.3	Percent change
Change From Baseline in Direct LDL-C at Week 8	SCH 900271 10 mg	-1.5	Standard Error 1.3	Percent change
Change From Baseline in Direct LDL-C at Week 8	SCH 900271 5 mg	-4.2	Standard Error 1.3	Percent change
Change From Baseline in Direct LDL-C at Week 8	SCH 900271 2.5 mg	0.2	Standard Error 1.3	Percent change
Change From Baseline in Direct LDL-C at Week 8	SCH 900271 1 mg	1.2	Standard Error 1.3	Percent change
Change From Baseline in Direct LDL-C at Week 8	Placebo	1.5	Standard Error 1.4	Percent change
Change From Baseline in Direct Non-HDL-C at Week 8	SCH 900271 15 mg	-2.1	Standard Error 1.2	Percent change
Change From Baseline in Direct Non-HDL-C at Week 8	SCH 900271 10 mg	-2.7	Standard Error 1.2	Percent change
Change From Baseline in Direct Non-HDL-C at Week 8	SCH 900271 5 mg	-3.5	Standard Error 1.2	Percent change
Change From Baseline in Direct Non-HDL-C at Week 8	SCH 900271 2.5 mg	-0.5	Standard Error 1.3	Percent change

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SCH 900271 15 mg	104
Overall Study	STARTED	SCH 900271 10 mg	105
Overall Study	STARTED	SCH 900271 5 mg	104
Overall Study	STARTED	SCH 900271 2.5 mg	104
Overall Study	STARTED	SCH 900271 1 mg	105
Overall Study	STARTED	Placebo	97
Overall Study	COMPLETED	SCH 900271 15 mg	93
Overall Study	COMPLETED	SCH 900271 10 mg	89
Overall Study	COMPLETED	SCH 900271 5 mg	99
Overall Study	COMPLETED	SCH 900271 2.5 mg	100

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events138

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal discomfort	Gastrointestinal disorders	SCH 900271 15 mg	1	103	1
other	Abdominal discomfort	Gastrointestinal disorders	SCH 900271 10 mg	6	105	6
other	Abdominal discomfort	Gastrointestinal disorders	SCH 900271 5 mg	2	104	2
other	Abdominal discomfort	Gastrointestinal disorders	SCH 900271 2.5 mg	0	104	0
other	Abdominal discomfort	Gastrointestinal disorders	SCH 900271 1 mg	0	105	0
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	0	97	0
other	Abdominal pain upper	Gastrointestinal disorders	SCH 900271 15 mg	1	103	1
other	Abdominal pain upper	Gastrointestinal disorders	SCH 900271 10 mg	6	105	7
other	Abdominal pain upper	Gastrointestinal disorders	SCH 900271 5 mg	1	104	1
other	Abdominal pain upper	Gastrointestinal disorders	SCH 900271 2.5 mg	1	104	1

1 to 10 of 138Source ClinicalTrials.gov

See all 138 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SCH 900271 15 mg
Total, all-cause mortality	SCH 900271 10 mg
Total, all-cause mortality	SCH 900271 5 mg
Total, all-cause mortality	SCH 900271 2.5 mg
Total, all-cause mortality	SCH 900271 1 mg
Total, all-cause mortality	Placebo
Total, other adverse events	SCH 900271 15 mg	41	103
Total, other adverse events	SCH 900271 10 mg	41	105
Total, other adverse events	SCH 900271 5 mg	19	104
Total, other adverse events	SCH 900271 2.5 mg	8	104

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00941603

GET https://conductscience.org/api/trials/v1/NCT00941603/events?page=2

API reference For AI assistants