Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009_542 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK1903 |
|
| 2 | Placebo Comparator | Placebo to MK1903 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK1903 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) | Baseline and Week 4 | |
| Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Triglycerides (mg/dL) | Baseline and 4 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
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).
Participants were recruited at 26 sites in 8 different countries from February 2009 to August 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 4 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | MedDRA (12.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C573553 | 1a,3,5,5a-tetrahydro-1H-2,3-diazacyclopropa(a)pentalene-4-carboxylic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: Placebo | Drug | 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. |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region | Ex-United States: Malaysia, Canada, Peru, Philipines, Colombia, Sweden, Finland | Number | participants |
|
| Body Mass Index (BMI) Category | Number | participants |
|
| Coronary Heart Disease (CHD) Risk Category | Number | Participants |
|
| Prior Niacin History | Number | Participants |
|
| Glycemic Status | Number | Participants |
|
| Weight | Mean | Standard Deviation | Kilogram |
|
| Height | Mean | Standard Deviation | Centimeter |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Pulse | Mean | Standard Deviation | beats/minute |
|
|
|
|
| Primary | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 4 |
|
|
|
|
| Secondary | Percent Change From Baseline in Triglycerides (mg/dL) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and 4 Weeks |
|
|
|
|
| 0 |
| 116 |
| 76 |
| 116 |
| EG001 | 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. | 0 | 75 | 26 | 75 |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
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.
| No |
| Superiority or Other |