TCTR20221209001Unknown4 期
Short term efficacy and safety of generic rosuvastatin (K-zuva) versus brand rosuvastatin (Crestor) for the treatment in patients with hypercholesterolemia
Health System Research Institute0 个研究点目标入组 240 人开始时间: 2022年12月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
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
- 35 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Age >/= 35 years
- •2. LDL-C level according to criteria
排除标准
- •1. Uncontrolled DM within 3 mounts before screening visit or HbA1C >8%
- •2. Serum triglyceride >/= 500mg/dL
- •3. History of uncontrolled thyroid disease with in 1 year before screening
- •4. History of gastrointestinal disease
- •5. AST, ALT, alkaline phosphate, bilirubin any value more than 2 times of upper limit of normal for the reference laboratory
- •6. Serum creatinine more than 2 .0 mg/dL
- •7. Creatinine phosphokinase(CPK) more than 2-fold the upper limit of normal
- •8. Uncontrolled hypertension(DBP > 100 mmHg or SBP > 160 mmHg)
- •9. Unstable angina, Congestive heart failure or orther uncontrolled cardiac disease
- •10. Female who is pregnant or breast-feeding
- •11. History of substance abuse or have a mental illness that may affect protocol compliance
- •12. History of take dietary supplement products that have medical evidence for reduce lipid level
- •13. Drinking every day (Beer more than 12 ounce, Wine more than 6 ounce or Alcohol more than 2 ounce)
- •14. Any disorder, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
- •15. Participation in any clinical trial with in 30 days before screening
- •16. History of any medication taken that may interact with rosuvastatin
研究者
相似试验
进行中（未招募）
不适用
A phase IIIb, efficacy, and safety study of rosuvastatin in children and adolescents 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH): a 12-week, double-blind, randomized, multi-center, placebo-controlled study with a 40-week, open-label, follow-up period. - PLUTOHeterozygous familial hypercholesterolemia (HeFH) is a frequent, inherited disorderof lipoprotein metabolism caused by mutations in the LDL receptor gene. The risk of CHD is approximately 50% by 50 years of age in untreated HeFH. Morphological and functional changes of the arteries are present in hypercholesterolemic children and can predict future CHD, underscoring the importance of aggressive and early treatment of dyslipidemia to prevent premature events in HeFH.EUCTR2006-002616-96-Outside-EU/EEAAstraZeneca AB200
已完成
不适用
Study of effectiveness and safety of roxadustat for renal anemia in dialysis patientsRenal anemia in dialysis patientsJPRN-UMIN000039234agakubo Hospital8
进行中（未招募）
1 期
A Phase IIIb, efficacy, and safety study of rosuvastatin in children and adolescents 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH): a 12-week, double-blind, randomized, multi-center, placebo-controlled study with a 40-week, open-label, follow-up period. - PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatiEUCTR2006-002616-96-NLAstraZeneca AB222
已完成
2 期
Effect of drug Rosuvastatin When given in addition to the existing treatment in patients of skin disease (chronic plaque psoriasis)CTRI/2023/02/049424Pt BD Sharma PGIMS Rohtak48
招募中
4 期
Efficacy and safety of rosuvastatin combined with Shouhui Tongbian capsule in the treatment of dyslipidemia: a prospective, single-center, open, randomized controlled studyDyslipidemiaITMCTR2100004388Beijing Friendship Hospital Affiliated to Capital Medical University