EUCTR2015-003049-24-SE进行中（未招募）1 期
The Precision Hypertension Care study - PHYSIC
ppsala University, Department of Medical Sciences0 个研究点目标入组 300 人开始时间: 2016年3月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •1. Male or female aged =40 years and =75 years
- •2. Previously diagnosed with hypertension with systolic blood pressure between 140 and 159 mm Hg within five years prior to the start of the trial.
- •3. Pharmacologically untreated or using blood pressure-lowering monotherapy at Visit 1. No blood pressure-lowering medication taken during the placebo run-in period.
- •4. Office systolic blood pressure between 140 and 179 mm Hg and diastolic blood pressure at or below 109 mm Hg at Visit 2.
- •5. Patients must give informed consent to participate in the study.
- •6 Access to a smartphone.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Medical history, clinical signs or laboratory results indicating secondary hypertension.
- •2. Evidence of serious hematological, respiratory immunological, renal, hepatic, gastrointestinal, endocrinological, metabolic, neurologic, malignant, psychiatric or other diseases as revealed by medical history, physical examination and/or laboratory assessments.
- •3. Lithium treatment and gout.
- •4. Previous or present arterial occlusive diseases such as myocardial infarction (MI), stroke or acute arterial insufficiency (unstable angina pectoris or transient ischemic attacks, (TIA)) or heart failure (NYHA class III or IV).
- •5. Symptomatic hypotension, defined as weakness or syncope upon rising to an erect position associated with a decrease in systolic blood pressure.
- •6. Patients with diabetes requiring insulin or oral glucose-lowering drugs.
- •7. Patients with history of serious abnormal drug reaction including angioedema.
- •8. Patients with any condition associated with poor compliance including alcoholism or drug dependence.
- •9. Patients who will not comply with the study protocol as judged by the Investigator.
- •10. Women who are pregnant or lactating or not using appropriate contraception for at least 3 months prior to visit 1.
- •11. Patient using concomitant medication that can interfere with study medication, and that according to FASS should not be given.
- •12. Clinical laboratory assessment outside normal range at visit 1 as judged by Investigator.
- •13. Previous enrolment in present study.
研究者
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