Trial Outcomes & Findings for A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004) (NCT NCT00847197)

NCT ID: NCT00847197

Last Updated: 2015-12-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

191 participants

Primary outcome timeframe

Baseline and Week 4

Results posted on

2015-12-21

Participant Flow

Participants were recruited at 26 sites in 8 different countries from February 2009 to August 2009.

Participants had a 2-week placebo run-in period prior to randomization. 402 participants were screened of which 211 participants were excluded (194 participants did not meet inclusion criteria, 15 participants withdrew, 1 participant was lost to follow-up and 1 participant had an adverse event).

Participant milestones

Participant milestones
Measure	MK1903 Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Overall Study STARTED	116	75
Overall Study COMPLETED	92	70
Overall Study NOT COMPLETED	24	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MK1903 Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Overall Study Adverse Event	21	3
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK1903 n=116 Participants Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo n=75 Participants Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Total n=191 Participants Total of all reporting groups
Age, Continuous	52.6 years STANDARD_DEVIATION 10.4 • n=5 Participants	50.9 years STANDARD_DEVIATION 11.1 • n=7 Participants	51.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	28 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	47 Participants n=7 Participants	118 Participants n=5 Participants
Region United States	56 participants n=5 Participants	38 participants n=7 Participants	94 participants n=5 Participants
Region Ex-United States	60 participants n=5 Participants	37 participants n=7 Participants	97 participants n=5 Participants
Body Mass Index (BMI) Category < 25	20 participants n=5 Participants	14 participants n=7 Participants	34 participants n=5 Participants
Body Mass Index (BMI) Category 25 - 30	65 participants n=5 Participants	42 participants n=7 Participants	107 participants n=5 Participants
Body Mass Index (BMI) Category 31 - 39	28 participants n=5 Participants	17 participants n=7 Participants	45 participants n=5 Participants
Body Mass Index (BMI) Category => 40	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Coronary Heart Disease (CHD) Risk Category Low Risk	90 Participants n=5 Participants	59 Participants n=7 Participants	149 Participants n=5 Participants
Coronary Heart Disease (CHD) Risk Category Multiple Risk	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Prior Niacin History Yes	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Prior Niacin History No	106 Participants n=5 Participants	64 Participants n=7 Participants	170 Participants n=5 Participants
Glycemic Status Normal (< 100 mg/dL)	79 Participants n=5 Participants	53 Participants n=7 Participants	132 Participants n=5 Participants
Glycemic Status Impaired Fasting Glucose ( ≥ 100 & ≤ 125 mg/dL)	36 Participants n=5 Participants	21 Participants n=7 Participants	57 Participants n=5 Participants
Glycemic Status Others (> 125 mg/dL)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Weight	81.9 Kilogram STANDARD_DEVIATION 17.9 • n=5 Participants	81.6 Kilogram STANDARD_DEVIATION 17.5 • n=7 Participants	81.7 Kilogram STANDARD_DEVIATION 17.7 • n=5 Participants
Height	168.3 Centimeter STANDARD_DEVIATION 10.5 • n=5 Participants	167.9 Centimeter STANDARD_DEVIATION 10.2 • n=7 Participants	168.2 Centimeter STANDARD_DEVIATION 10.3 • n=5 Participants
Body Mass Index	28.7 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants	28.7 kg/m^2 STANDARD_DEVIATION 4.5 • n=7 Participants	28.7 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants
Systolic Blood Pressure	122.9 mm Hg STANDARD_DEVIATION 13.6 • n=5 Participants	122.3 mm Hg STANDARD_DEVIATION 13.5 • n=7 Participants	122.7 mm Hg STANDARD_DEVIATION 13.5 • n=5 Participants
Diastolic Blood Pressure	77.9 mm Hg STANDARD_DEVIATION 8.9 • n=5 Participants	77.1 mm Hg STANDARD_DEVIATION 9.0 • n=7 Participants	77.6 mm Hg STANDARD_DEVIATION 8.9 • n=5 Participants
Pulse	67.8 beats/minute STANDARD_DEVIATION 8.8 • n=5 Participants	68.5 beats/minute STANDARD_DEVIATION 8.9 • n=7 Participants	68.1 beats/minute STANDARD_DEVIATION 8.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	MK1903 n=112 Participants Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo n=75 Participants Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)	-0.3 Percent Change Standard Deviation 16.3	-1.5 Percent Change Standard Deviation 12.9

PRIMARY outcome

Timeframe: Baseline and Week 4

Outcome measures

Outcome measures
Measure	MK1903 n=112 Participants Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo n=75 Participants Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)	6.0 Percent Change Standard Deviation 13.0	0.7 Percent Change Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline and 4 Weeks

Outcome measures

Outcome measures
Measure	MK1903 n=112 Participants Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo n=75 Participants Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Percent Change From Baseline in Triglycerides (mg/dL)	-13.2 Percent Change Standard Deviation 32.7	-2.0 Percent Change Standard Deviation 39.5

Adverse Events

MK1903

Serious events: 0 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK1903 n=116 participants at risk Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.	Placebo n=75 participants at risk Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Eye disorders Eye disorders	0.86% 1/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	2.7% 2/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Gastrointestinal disorders Gastrointestinal disorders	2.6% 3/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	4.0% 3/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
General disorders General disorders and administration site conditions	0.00% 0/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	5.3% 4/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Infections and infestations Infections and infestations	4.3% 5/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	5.3% 4/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	4.3% 5/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	4.0% 3/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Investigations Investigations	2.6% 3/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	1.3% 1/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	3.4% 4/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	5.3% 4/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Nervous system disorders Nervous system disorders	15.5% 18/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	6.7% 5/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	4.3% 5/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	0.00% 0/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	27.6% 32/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	2.7% 2/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.
Vascular disorders Vascular disorders	36.2% 42/116 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.	10.7% 8/75 • Reported Adverse Event (AE) data were collected from 6-Feb-09 to 5-Oct-09. AE information was collected by continuous monitoring of participant's labs and clinical symptoms during the course of the study. AEs were usually reported during routine clinic visits and the 14-day telephone contact conducted after the participant's last visit and the expected date of Visit 4 for discontinued participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER