EUCTR2004-000354-22-IE进行中（未招募）1 期
An International, Multicentre, Open Label Study To Assess The Effectiveness OfAmlodipine –Atorvastatin Combination In Subjects With Hypertension andDyslipidaemia. (The JEWEL II Study) - JEWEL II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
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
- •Treated or untreated subjects diagnosed with concurrent hypertension
- •and dyslipidaemia, qualifying for drug treatment according to the
- •governing guidelines.
- •The BP level to be used for eligibility assessment will be the average of
- •the levels obtained at the qualifying visits. Blood pressure must be not
- •at target as defined by governing guidelines.
- •The LDL-C level to be used for eligibility assessment is a single value
- •obtained at screening. LDL-C may be at target on medication or not at
- •target with or without medication as defined by governing guidelines.
- •For subjects receiving dyslipidaemia and/or antihypertensive therapy at
- •screening, the doses of medication must be stable for at least 6 weeks
- •prior to baseline assessments.
- •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
- •Subjects whose BP is adequately maintained at target with or without
- •medication;
- •Subjects who are currently treated with both amlodipine and
- •atorvastatin;
- •Subjects who are being treated with amlodipine 10 mg or other maximum dose calcium channel blockade therapy, or have a serum LDL-C concentration =
- •2.5mmol/L(100 mg/dL) while being treated with atorvastatin 80 mg.
研究者
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