JPRN-jRCT2031220230进行中（未招募）3 期
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled by Their Lipid-Modifying Therapies - TA-8995-302
Toshihiro Hokonohara0 个研究点目标入组 175 人开始时间: 2022年7月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Are willing and able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures
- •2. Are male or female 18 years and more of age at Screening
- •Females may be enrolled if all 3 of the following criteria are met
- •- They are not pregnant
- •- They are not breastfeeding and
- •- They do not plan on becoming pregnant during the study
- •3. Have underlying heterozygous familial hypercholesterolemia (HeFH) and or a history of established ASCVD
- •4. Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows
- •- maximally tolerated statin, at a stable dose for at least 8 weeks prior to Screening
- •- Atorvastatin 10 or 20 mg for non-familial hypercholesterolemia (Japan only)
- •- Atorvastatin 20 or 40 mg for heterozygous familial hypercholesterolemia (Japan only) or
- •Rosuvastatin 10 or 20 mg (Japan only)
- •- Ezetimibe for at least 8 weeks prior to Screening
- •- Bempedoic acid for at least 8 weeks prior to Screening
- •- A PCSK-9 targeted therapy for at least 4 stable doses prior to Screening
- •5. Have a fasting serum LDL-C as follows:
- •- Fasting serum LDL-C 55 and more and under 100 mg/dL (1.4 and more and under 2.6 mmol/L) OR non-HDL-C 85 mg/dL (2.2 mmol/L) and more to under 130 mg/dL (3.4 mmol/L) with at least 1 of the following risk enhancers at Screening;
- •- Recent MI (more than 3 and under 12 months prior to Randomization);
- •- Type 2 diabetes mellitus;
- •- Current daily cigarette smoking;
- •- Age of more than 60 years;
- •- High sensitivity C-reactive protein 2.0 mg/L (19.05 nmol/L) and more at Screening or within 6 months prior to Screening;
- •- Fasting triglycerides (TG) mor than 150 mg/dL (1.7 mmol/L);
- •- Fasting lipoprotein (a) more than 30 mg/dL (70 nmol/L); and/or
- •- Fasting HDL-C under 40 mg/dL (1.0 mmol/L);
- •- Fasting serum LDL-C 100 mg/dL (2.6 mmol/L) and more OR non-HDL-C 130 mg/dL (3.4 mmol/L) and more
- •6. Fasting triglyceride (TG) under 500 mg/dL (5.7 mmol/L) at Screening; and
- •7. Have an estimated glomerular filtration rate (eGFR) 30 mL/min/1.73m2 and more at Screening
排除标准
- •1. New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction under 30%
- •2. Hospitalized for heart failure within 5 years prior to Screening
- •3. Major adverse cardiac event (MACE) within 3 months prior to Screening
- •4. Uncontrolled severe hypertension, defined as either systolic blood pressure 160 mmHg and more or diastolic blood pressure 100 mmHg and more prior to Randomization
- •5. Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
- •6. Active liver disease
- •7. HbA1c 10% and more or a fasting glucose 270 mg/dL and more at Screening
- •8. Thyroid-stimulating hormone over 1.5 X upper limit of normal (ULN) at Screening
- •9. Creatine kinase 3 X upper limit of normal (ULN) at Screening
- •10. History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization
- •11. Known history of alcohol and/or drug abuse within 5 years prior to Screening
- •12. Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer
- •13. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
- •14. Planned use of other investigational products or devices during the course of the study;
- •15. Participated in any clinical trial evaluating obicetrapib; or
- •16. Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
- •17. Any condition that, according to the Investigator, could interfere with the conduct of the study
- •18. Patients who meet the lipid management targets as specified in the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (only for Japan); or
- •19. Have an existing diagnosis of CETP deficiency (only for Japan)
研究者
相似试验
招募中
3 期
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL C >= 70 mg/dL Who are Not Adequately Controlled by Their Lipid Modifying Therapieshigh cholesterol10013317Familial hypercholesterolemiaNL-OMON53451ewAmsterdam Pharma B.V.9
进行中（未招募）
1 期
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL-C =70 mg/dL Who are Not Adequately Controlled by Their Lipid-Modifying Therapiesdyslipidemiaheterozygous familial hypercholesterolemia (HeFH)MedDRA version: 20.1Level: LLTClassification code 10020049Term: High cholesterolSystem Organ Class: 100000004848MedDRA version: 20.0Level: LLTClassification code 10057079Term: Heterozygous familial hypercholesterolemiaSystem Organ Class: 100000004850EUCTR2021-005064-22-NLewAmsterdam Pharma B.V.354
进行中（未招募）
1 期
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL-C =70 mg/dL Who are Not Adequately Controlled by Their Lipid-Modifying Therapiesdyslipidemiaheterozygous familial hypercholesterolemia (HeFH)MedDRA version: 20.1Level: LLTClassification code 10020049Term: High cholesterolSystem Organ Class: 10022891 - InvestigationsMedDRA version: 20.0Level: LLTClassification code 10057079Term: Heterozygous familial hypercholesterolemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-005064-22-PLewAmsterdam Pharma B.V.354
已完成
不适用
Olaparib dose escalation in combination with high dose radiotherapy to the breast and regional lymph nodes in patients with breast cancermetastatic breast cancer10006291breast cancerNL-OMON44691ederlands Kanker Instituut72
招募中
不适用
Olaparib dose escalating trial in patients treated with radiotherapy with of without daily dose Cisplatin for locally advanced non-small cell lung carcinoma.10038666lung cancerNL-OMON39751Antoni van Leeuwenhoek Ziekenhuis72