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

NCT00847197 | Completed Phase 2 Results

• 2 other identifiers: 1903-0042009_542
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Percent Change From Baseline in Triglycerides (mg/dL)

  Baseline and 4 Weeks

Study Arms (2)

1

EXPERIMENTAL

MK1903

Drug: MK1903

2

PLACEBO COMPARATOR

Placebo to MK1903

Drug: Comparator: Placebo

Interventions

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.

1

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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is not on a statin or other lipid-modifying therapy
• Low or moderate risk participant
• Male participants, and female participants not of reproductive potential

You may not qualify if:

• Female participant of reproductive potential
• Participant is pregnant, breastfeeding, or expecting to conceive during the study
• Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
• Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
• Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
• Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
• Participant is currently experiencing menopausal hot flashes
• Participant currently engages in vigorous exercise or an aggressive diet regimen
• Participant is at high risk for heart conditions
• Participant has Type 1 or Type 2 diabetes mellitus
• Participant has poorly controlled cardiac arrhythmias
• Participant has a history of stroke or other hemorrhage
• Participant has poorly controlled high blood pressure
• Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
• Participant has a disease of the kidney or liver

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

1a,3,5,5a-tetrahydro-1H-2,3-diazacyclopropa(a)pentalene-4-carboxylic acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 21, 2015
• Results First Posted: September 22, 2010

Record last verified: 2015-11