EUCTR2009-010615-32-NL进行中（未招募）不适用
A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers, infarct size, and cardiac function in subjects with myocardial infarction without STsegmentelevation - SOLSTICE
GlaxoSmithKline R&D Ltd0 个研究点目标入组 400 人开始时间: 2009年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects with a NSTEMI, defined as:
- •symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, and occurring within the 24 hours prior to presentation,
- •without persistent ST-segment elevation on admission 12-lead ECG, and
- •with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation.
- •2. Subject able to be randomized within 12 hours of presentation.
- •3. Subjects likely to be managed with an early invasive strategy, with PCI likely to
- •occur at least 2 hours after the start of dosing.[subjects who do not undergo PCI
- •will not be withdrawn from study].
- •4. Male or female subject who is 45 years of age or older.
- •5. A female subject is eligible to participate if she is of:
- •Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory), or
- •Child-bearing potential and agrees to use one of the contraception methods listed in Section 7.1.1 of the protocol for the duration of dosing and until the first follow-up visit (~2 weeks post last-dose).
- •6. Negative urine or serum pregnancy test (in women of child-bearing potential only).
- •7. Male subjects must agree to use one of the contraception methods listed in Section 7.1.2 of the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (~2 weeks post last-dose).
- •8. QTcB or QTcF 9. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction (EF) < 30%] regardless of symptomatic status.
- •2. Suspected aortic dissection.
- •3. Severe aortic stenosis or other severe valvular disease.
- •4. Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
- •5. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions
- •known to be associated with active chronic or acute inflammation (e.g. inflammatory
- •bowel disease, osteomyelitis, pneumonia, sepsis, etc.). Intermittent conditions
- •treated with short-term oral antibiotics (e.g. typical URI), or conditions that are
- •not currently exacerbated (e.g. gout with no current flair) may be included.
- •6. History of myopathy or rhabdomyolysis.
- •7. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •8. Known to be Hepatitis B or Hepatitis C positive.
- •9. Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal
- •and topical steroids are allowed. A single prophylactic dose of systemic steroid
- •is allowed at time of PCI for subjects with contrast allergy.
- •10. Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone);
- •Previously diagnosed cancer that has not been in complete remission for at least
- •5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix
- •that have been resected or ablated for cure are not exclusionary.11.
- •12. Known alcohol or drug abuse within the past 6 months.
- •13. Previous exposure to GW856553.
- •14. Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study.
- •15. Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication noncompliance).
- •16. Unwillingness or inability to follow the procedures outlined in the protocol.
研究者
相似试验
已完成
3 期
A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.Dravet syndrome10039911NL-OMON44663GW Research Ltd.30
已完成
2 期
A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)Primary palmar hyperhidrosisJPRN-UMIN000020647Osaka University Hospital45
已完成
3 期
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritisGiant Cell ArteritisTemporal ArteritisHorton DiseaseNL-OMON45913Sanofi-aventis18
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia - RESTORETS (lower urinary tract symptoms) associated with BPH (benign prostatic hyperplasia)EUCTR2005-001627-11-SKYamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V., as of August 2005)1,051
尚未招募
1 期
A randomized, double-blind, placebo-controlled study of Jieyu Xifeng Decoction in the treatment of anxiety insomniaITMCTR2000003796Shanghai Hospital of traditional Chinese Medicine