EUCTR2004-000305-21-GB进行中（未招募）1 期
A randomized, placebo-controlled, double-blind, six-arm, dose escalation, multi-center study to evaluate the efficacy and safety of SLV306: 150, 300, 600 mg once daily, 150-300 mg twice daily and amlodipine 5-10 mg once daily in subjects with hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 522
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
- •Inclusion criteria at screening:
- •1.Male or female patients =18 with hypertension. Females must be without childbearing potential.
- •2.Documented history of mild to moderate hypertension.
- •3.Sitting office diastolic blood pressure = 109 mmHg.
- •Inclusion criteria at baseline:
- •Sitting office diastolic blood pressure = 90 mmHg and = 109 mmHg
- •Sitting office systolic blood pressure = 140 mmHg and = 179 mmHg
- •Mean 24-ABPM day-time diastolic blood pressure = 85 mmHg
- •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.Any woman of child-bearing potential who is pregnant, lactating, or not using a medically approved contraceptive method for at least 3 months prior to Visit 1.
- •2.Evidence of any respiratory, urogenital, gastrointestinal / hepatic, hematological /
- •immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic / connective tissue, musculoskeletal, metabolic / nutritional, endocrine, neurologic / psychiatric diseases, allergy, major surgery or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which might limit participation in or completion of the study.
- •3.Concomitant use of other investigational drugs
- •4.Severe allergy or any history of severe abnormal drug reaction to amlodipine
- •5.Previous participation in any study with SLV306, including previous participation in this study.
- •6.Treatment for malignancy, except for basal cell carcinoma of the skin, within 12 months prior to Visit 1
- •7.Significant hepatic disease (two times the upper limit of normal ALT and AST) as measured at Visit 1.
- •8.Significantly reduced renal function (creatinine = 200 µmol/L) as measured at Visit 1.
研究者
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