2024-516967-10-00招募中4 期
The relationship of cholesterol-lowering drugs with steroid HORMONEs, bile acids, muscle morphology, vitamin D, the immune system and related diseases such as depression and osteoporosis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Changes in sex steroid levels
研究概览
简要总结
Do cholesterol-lowering drugs reduce the levels of steroid hormones?
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for all cohorts except the new-onset low-dose statin therapy patient group: - Age 18–75 years - LDL cholesterol levels >116 mg/dl - Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with either atorvastatin >=40 mg, rosuvastatin >=20 mg or PCSK-9 inhibitors such as Praluent, Repatha or Inclisiran Inclusion criteria for the new-onset low-dose statin therapy patient group: - No history of statin treatment - Age 18–75 years - LDL cholesterol levels >116 mg/dl before statin treatment - Previously prescribed dyslipidemia treatment according to the ESC/EAS guidelines with simvastatin <=20 mg, atorvastatin <=10 mg or rosuvastatin <=10 mg
排除标准
- •Severe liver disease - Pregnancy - Malignant disorders - Hepatitis B and Hepatitis C - HIV - Primary psychiatric disorder other than depression (ICD-10: F32 and F33) - Exclusion criteria for the MR investigations: claustrophobia, implants in the human body that do not fit to the guidelines on the feasibility of MR measurements.
结局指标
主要结局
Changes in sex steroid levels
Changes in sex steroid levels
次要结局
未报告次要终点
研究者
Division of Endocrinology and Metabolism, Department of Medicine III
Scientific
Medical University Of Vienna
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Age-Related Maculopathy Statin StudyEye - Diseases / disorders of the eyeAge-related macular degenerationACTRN12605000320651Centre for Eye Research Australia300
已完成
不适用
Crossover study on blood cholesterol reduction by pregelatinized brown rice ingestedDL cholesterol 120 ~ 159 mg / dL and, BMI 23 ~ 30. Healthy people.JPRN-UMIN000015710Hitachi health management center120
进行中（未招募）
1 期
SPECTREA single arm Phase II study to test if adding statins to hormone treatment will result in better cancer control in patients with hormone resistant prostate cancer.Castration Resistant Prostate CancerMedDRA version: 18.1Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864EUCTR2015-003720-32-GBHS Greater Glasgow and Clyde40
已完成
不适用
Effect of cholesterol lowering on progression of aortic stenosis in patients with mild to moderate aortic stenosisAortic stenosis (AS)Circulatory SystemNonrheumatic aortic valve disordersISRCTN32424163niversity of Ottawa (Canada)264
进行中（未招募）
不适用
Additiv kolesterolsænkende effekt ved kombinationsbehandling med psyllium frøskaller og sojaproteinisolat i tillæg til hjerterigtig kost hos hyperkolesterolæmipatienter - ProFi studietMedDRA version: 12.1Level: LLTClassification code 10020604Term: HypercholesterolemiaHypercholesterolemiaEUCTR2010-022822-34-DKipidklinikken, Aalborg Sygehus