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)
2017年12月7日 更新者：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.
調査の概要
詳細な説明
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
研究の種類
介入
入学 (実際)
1623
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Anacetrapib
Participants randomly assigned to anacetrapib in base study will continue same treatment if enrolled in study extension.
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Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.
他の名前：
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プラセボコンパレーター：Placebo
Participants randomly assigned to placebo in base study will continue same treatment if enrolled in study extension.
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Participants will receive one placebo tablet once daily for 76 weeks.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline in Low Density Lipoprotein Cholesterol
時間枠：Baseline and 24 weeks
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Baseline and 24 weeks
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Number of participants with hepatitis-related adverse experiences
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with Alanine Transaminase consecutive elevations greater than or equal to 3xULN (Upper Limit of Normal)
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with Aspartate Aminotransferase consecutive elevations greater than or equal to 3xULN
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with Creatine Phosphokinase elevations greater than or equal to 10xULN
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with Creatine Phosphokinase elevations greater than or equal 10xULN with muscle symptoms
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with sodium, chloride, or bicarbonate elevations greater than ULN
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with reduction in potassium levels less than LLN (Lower Limit of Normal)
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with myalgia
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with rhabdomyolysis
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with pre-specified adjudicated cardiovascular serious adverse events
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with death from any cause
時間枠：Through 88 weeks
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Through 88 weeks
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Number of participants with significant increase in Blood Pressure
時間枠：Through 88 weeks
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Through 88 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline in High Density Lipoprotein Cholesterol
時間枠：Baseline, 24 weeks, and 76 weeks
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Baseline, 24 weeks, and 76 weeks
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Change from baseline in non-High Density Lipoprotein Cholesterol
時間枠：Baseline, 24 weeks, and 76 weeks
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Baseline, 24 weeks, and 76 weeks
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Change from baseline in Apolipoprotein B
時間枠：Baseline, 24 weeks, and 76 weeks
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Baseline, 24 weeks, and 76 weeks
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Change from baseline in Apolipoprotein A-1
時間枠：Baseline, 24 weeks, and 76 weeks
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Baseline, 24 weeks, and 76 weeks
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Change from baseline in Low Density Lipoprotein Cholesterol
時間枠：Baseline, 24 weeks, and 76 weeks
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Baseline, 24 weeks, and 76 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Brinton EA, Kher U, Shah S, Cannon CP, Davidson M, Gotto AM, Ashraf TB, McCrary Sisk C, Dansky H, Mitchel Y, Barter P; DEFINE Investigators. Effects of anacetrapib on plasma lipids in specific patient subgroups in the DEFINE (Determining the Efficacy and Tolerability of CETP INhibition with AnacEtrapib) trial. J Clin Lipidol. 2015 Jan-Feb;9(1):65-71. doi: 10.1016/j.jacl.2014.10.005. Epub 2014 Nov 4.
- Gotto AM Jr, Kher U, Chatterjee MS, Liu Y, Li XS, Vaidya S, Cannon CP, Brinton EA, Moon JE, Shah S, Dansky HM, Mitchel Y, Barter P; DEFINE Investigators. Lipids, safety parameters, and drug concentrations after an additional 2 years of treatment with anacetrapib in the DEFINE study. J Cardiovasc Pharmacol Ther. 2014 Nov;19(6):543-9. doi: 10.1177/1074248414529621. Epub 2014 Apr 14.
- Cannon CP, Shah S, Dansky HM, Davidson M, Brinton EA, Gotto AM, Stepanavage M, Liu SX, Gibbons P, Ashraf TB, Zafarino J, Mitchel Y, Barter P; Determining the Efficacy and Tolerability Investigators. Safety of anacetrapib in patients with or at high risk for coronary heart disease. N Engl J Med. 2010 Dec 16;363(25):2406-15. doi: 10.1056/NEJMoa1009744. Epub 2010 Nov 17.
- Cannon CP, Dansky HM, Davidson M, Gotto AM Jr, Brinton EA, Gould AL, Stepanavage M, Liu SX, Shah S, Rubino J, Gibbons P, Hermanowski-Vosatka A, Binkowitz B, Mitchel Y, Barter P; DEFINE investigators. Design of the DEFINE trial: determining the EFficacy and tolerability of CETP INhibition with AnacEtrapib. Am Heart J. 2009 Oct;158(4):513-519.e3. doi: 10.1016/j.ahj.2009.07.028.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2008年3月24日
一次修了 (実際)
2009年7月2日
研究の完了 (実際)
2017年11月23日
試験登録日
最初に提出
2008年5月23日
QC基準を満たした最初の提出物
2008年5月27日
最初の投稿 (見積もり)
2008年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月11日
QC基準を満たした最後の更新が送信されました
2017年12月7日
最終確認日
2017年12月1日
詳しくは
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