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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

1623

Fas

  • Fas 3

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Anacetrapib
Participants randomly assigned to anacetrapib in base study will continue same treatment if enrolled in study extension.
Läkemedel: anacetrapib
Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
Andra namn:
  • MK0859
Placebo-jämförare: Placebo
Participants randomly assigned to placebo in base study will continue same treatment if enrolled in study extension.
Läkemedel: Comparator: placebo
Participants will receive one placebo tablet once daily for 76 weeks.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck Sharp & Dohme LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 mars 2008

Primärt slutförande (Faktisk)

2 juli 2009

Avslutad studie (Faktisk)

23 november 2017

Studieregistreringsdatum

Först inskickad

23 maj 2008

Först inskickad som uppfyllde QC-kriterierna

27 maj 2008

Första postat (Uppskatta)

28 maj 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 december 2017

Senast verifierad

1 december 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 0859-019
  • 2007_648 (Annan identifierare: Merck Study Number)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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