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Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019) (DEFINE)

7. december 2017 opdateret af: Merck Sharp & Dohme LLC

A 76-Week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease

This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent disease on stable dose regimen of statin with or without other lipid-modifying therapy. The two year extension to this study will further evaluate the long-term safety profile and efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a statin with or without other lipid-modifying therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The 76 week treatment period is followed by a 12 week reversibility phase which can be extended by up to another 12 weeks in order to allow participants who have completed their week 88 visit to continue in the study until the Extension study is ready to be implemented.

In the optional extension, participants will be assigned to the same treatment arm to which they were assigned in the base study. The total duration of the extension study will be up to 116 weeks; which will include a 2 year treatment period, followed by a 12 week reversal phase. A post-extension study follow-up phone call will be completed 12 weeks after discontinuation or completion of study treatment. Participants previously treated with anacetrapib or placebo will be invited in a 4:1 ratio in an optional extended reversal phase. The total duration of the extended reversal phase will be 1 year.

Participants previously treated with anacetrapib in the DEFINE study will be followed periodically for up to 4 years to determine plasma levels of anacetrapib. Participants will also be invited to participate in a sub-study consisting of one clinic visit to measure anacetrapib levels in the plasma and the subcutaneous adipose tissue.

ACRONYM: DEFINE= Determining the EFficacy and Tolerability of Cholesteryl ester transfer protein (CETP) INhibition with AnacEtrapib

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1623

Fase

  • Fase 3

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Base Study:

    • Patient has Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease and is treated with a statin, with well controlled LDL-C

  • Extension Study:

    • Patient has completed the base study including the reversibility period (i.e. 12 or to up to 24 weeks).
    • Patient is on statin therapy ± lipid-modifying therapy since the end of the base study and planning to continue taking a statin throughout the study

Exclusion Criteria:

  • History of heart failure, arrhythmias, heart attack, unstable angina, or stroke within 3 months prior to screening, uncontrolled blood pressure, uncontrolled high cholesterol or liver disease.
  • History of mental instability, drug/alcohol abuse within the past 5 years
  • Pregnant or breast-feeding
  • History of cancer within the last 5 years
  • HIV positive
  • Donated blood products within 8 weeks
  • Currently participating or have participated in a study with an investigational compound within the last 30 days

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: Anacetrapib
Participants randomly assigned to anacetrapib in base study will continue same treatment if enrolled in study extension.
Medicin: anacetrapib
Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
Andre navne:
  • MK0859
Placebo komparator: Placebo
Participants randomly assigned to placebo in base study will continue same treatment if enrolled in study extension.
Medicin: Comparator: placebo
Participants will receive one placebo tablet once daily for 76 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in Low Density Lipoprotein Cholesterol
Tidsramme: Baseline and 24 weeks
Baseline and 24 weeks
Number of participants with hepatitis-related adverse experiences
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with Alanine Transaminase consecutive elevations greater than or equal to 3xULN (Upper Limit of Normal)
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with Aspartate Aminotransferase consecutive elevations greater than or equal to 3xULN
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with Creatine Phosphokinase elevations greater than or equal to 10xULN
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with Creatine Phosphokinase elevations greater than or equal 10xULN with muscle symptoms
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with sodium, chloride, or bicarbonate elevations greater than ULN
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with reduction in potassium levels less than LLN (Lower Limit of Normal)
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with myalgia
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with rhabdomyolysis
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with pre-specified adjudicated cardiovascular serious adverse events
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with death from any cause
Tidsramme: Through 88 weeks
Through 88 weeks
Number of participants with significant increase in Blood Pressure
Tidsramme: Through 88 weeks
Through 88 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in High Density Lipoprotein Cholesterol
Tidsramme: Baseline, 24 weeks, and 76 weeks
Baseline, 24 weeks, and 76 weeks
Change from baseline in non-High Density Lipoprotein Cholesterol
Tidsramme: Baseline, 24 weeks, and 76 weeks
Baseline, 24 weeks, and 76 weeks
Change from baseline in Apolipoprotein B
Tidsramme: Baseline, 24 weeks, and 76 weeks
Baseline, 24 weeks, and 76 weeks
Change from baseline in Apolipoprotein A-1
Tidsramme: Baseline, 24 weeks, and 76 weeks
Baseline, 24 weeks, and 76 weeks
Change from baseline in Low Density Lipoprotein Cholesterol
Tidsramme: Baseline, 24 weeks, and 76 weeks
Baseline, 24 weeks, and 76 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

24. marts 2008

Primær færdiggørelse (Faktiske)

2. juli 2009

Studieafslutning (Faktiske)

23. november 2017

Datoer for studieregistrering

Først indsendt

23. maj 2008

Først indsendt, der opfyldte QC-kriterier

27. maj 2008

Først opslået (Skøn)

28. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0859-019
  • 2007_648 (Anden identifikator: Merck Study Number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med anacetrapib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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