EUCTR2006-003286-14-GB进行中（未招募）不适用
A phase IV, 6-week, randomised, double-blind, multicentre, parallel group, comparative study to evaluate the efficacy of rosuvastatin 5 mg and atorvastatin 10 mg in UK Asian subjects with primary hypercholesterolaemia - SHUKRA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •For inclusion in the study dietary run-in period subjects must fulfil all of the following
- •1. Provision of written informed consent
- •2. Self-described Asian, first or second generation (includes origin of India, Pakistan,
- •Bangladesh, Sri Lanka, Nepal, Bhutan, Japan, China, Phillipines, Vietnam , Korea,
- •Indonesia and Malaysia, and the intention to reside in the UK for the duration of the
- •3. Males or females aged = 18 years. There is no upper age limit
- •4. Subjects with primary hypercholesterolaemia
- •5. Fasting LDL-C of 3.5 - 5.7 mmol/L (statin naive subjects) or 2.6 - 4.2 mmol/L (in subjects who have taken a statin within 4 weeks of Visit 1)and TG <4.52 mmol/L (all subjects) determined from blood samples collected at Visit 1
- •For inclusion into the treatment period of the study, subjects must fulfil the following criteria:
- •6. Fasting LDL-C of 3.5 - 5.7mmol/L (all subjects) and TG <4.52 mmol/L determined from blood samples collected at Visit 2
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1. Use of cholesterol-lowering drugs, the continued use of lipid-regulating dietary
- •supplements or food additives after Visit 1
- •2. History of serious hypersensitivity reactions to other HMG-CoA reductase
- •3. Pregnancy or lactation. Women of child bearing potential must have a negative
- •pregnancy test at Visit 1, and use a reliable method of contraception i.e. hormonal
- •contraceptives, double-barrier methods, intra-uterine device or tubal ligation, unless
- •their sexual partner is sterile
- •4. Active arterial disease such as unstable angina, myocardial infarction (MI), transient ischaemic attack (TIA), cerebrovascular accident (CVA), coronary artery bypass graft (CABG) surgery or angioplasty within 3-months of study entry
- •5. Poorly controlled diabetes, as defined by glycosylated haemoglobin (HbA1c) =9%
- •at Visit 1. Subjects with a history of diabetic ketoacidosis within the past 5-years
- •are also excluded
- •6. Uncontrolled hypothyroidism as defined as a thyroid stimulating hormone (TSH) >
- •1.5 X ULN at Visit 1 or subjects whose thyroid replacement therapy was initiated
- •within the last 3 months
- •7. History of alcohol and/or drug abuse during the preceding 5-years
- •8. Active liver disease or hepatic dysfunction, as defined by elevations of >3 x ULN at
- •Visit 1 in any of the following liver function tests: alanine aminotranferase (ALT),
- •aspartate aminotranferase (AST) or bilirubin
- •9. Unexplained serum creatine kinase (CK) >5 x ULN at Visit 1(eg., not due to recent
- •trauma, intra-muscular injections, heavy exercise etc)
- •10. Renal insufficiency as defined by serum creatinine >177µmol/L (2.0 mg/dL) at
- •11. Serious or unstable medical or psychological conditions that, in the opinion of the
- •investigator would compromise the subject’s safety or successful participation in
- •12. History of malignancy, except subjects who have been disease-free for more than 5 years, or whose malignancy has been basal or squamous cell skin carcinoma
- •13. History of homozygous familial hypercholesterolaemia
- •14. Previous enrolment or randomisation of treatment in this study
- •15. Participation in another clinical study during the last 90 days.
- •16. Use of contraindicated concomitant medications, as detailed in section 3.7
- •17. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- •Laboratory results should be reviewed in a timely manner from receipt at site, in order to assess patient’s eligibility for continuation into the dietary lead in/ wash-out period. Following review of results, if a subject no longer meets inclusion/ exclusion criteria the Investigator should contact the subject and inform them that they will no longer be required to participate in the study.
- •In addition, the following are regarded as criteria for exclusion into the randomised treatment period (Visit 3), determined from blood samples taken at visit 2:
- •18. Active liver disease or hepatic dysfunction, as defined by elevations of >3 x ULN in any of the following liver function tests: alanine aminotranferase (ALT), aspartate
- •aminotranferase (AST) or bilirubin at Visit 2
- •19. Unexplained serum creatine kinase (CK) >5 x ULN (eg., not due to recent trauma,
- •intra-muscular injections, heavy exercise etc) at Visit 2
- •20. Serum creatinine >177µmol/L (2.0 mg/dL) at Visit 2
研究者
相似试验
进行中（未招募）
不适用
A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritisJuvenile idiopathic arthritisEUCTR2014-003737-26-Outside-EU/EEAPfizer Inc201
进行中（未招募）
1 期
A randomised study, comparing FF/UMEC/VI single inhaler triple therapy, versus multiple inhaler therapy(budesonide/formoterol plus tiotropium) in participants with chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease (COPD)MedDRA version: 20.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-001150-33-DEGlaxoSmithKline Research & Development Limited732
进行中（未招募）
1 期
A randomised study, comparing FF/UMEC/VI single inhaler triple therapy, versus multiple inhaler therapy(budesonide/formoterol plus tiotropium) in participants with chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease (COPD)MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-001150-33-PTGlaxoSmithKline Research & Development Limited732
进行中（未招募）
1 期
A randomised study, comparing FF/UMEC/VI single inhaler triple therapy, versus multiple inhaler therapy(budesonide/formoterol plus tiotropium) in participants with chronic obstructive pulmonary diseaseEUCTR2017-001150-33-CZGlaxoSmithKline Research & Development Limited732
进行中（未招募）
1 期
A randomised study, comparing FF/UMEC/VI single inhaler triple therapy, versus multiple inhaler therapy(budesonide/formoterol plus tiotropium) in participants with chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease (COPD)MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-001149-28-DEGlaxoSmithKline Research & Development Limited732