A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
19. november 2015 opdateret af: Merck Sharp & Dohme LLC
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
191
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Participant has an ulcer within 3 months of screening
- Participant is Human Immunodeficiency Virus (HIV) positive
- Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
- Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
- Participant has taken an anti-obesity medication within 3 months of screening
- Participant is taking coumarins
- Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
- Participant is taking more than 100 mg aspirin per day
- Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
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 komparator: 2
Placebo to MK1903
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Tidsramme: Baseline and Week 4
|
Baseline and Week 4
|
|
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Tidsramme: Baseline and Week 4
|
Baseline and Week 4
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change From Baseline in Triglycerides (mg/dL)
Tidsramme: Baseline and 4 Weeks
|
Baseline and 4 Weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2008
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
18. februar 2009
Først indsendt, der opfyldte QC-kriterier
18. februar 2009
Først opslået (Skøn)
19. februar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1903-004
- 2009_542
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