EUCTR2007-005925-31-IT进行中（未招募）1 期
A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFECT OF 6-MONTH ACETYLCARNITINE THERAPY ON ARTERIAL BLOOD PRESSURE, LIPID AND METABOLIC PROFILE, AND KIDNEY FUNCTION IN HYPERTENSIVE PATIENTS WITH TYPE 2 DIABETES ON BACKGROUND SIMVASTATIN THERAPY (DIABASI STUDY) - Acetylcarnitine in type 2 diabetes
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 228 人开始时间: 2009年3月31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
- 228
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
入选标准
- •- Males and females >40 years old; - High-risk subjects with type 2 diabetes (WHO criteria); - High blood pressure (systolic blood pressure >140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months); - Serum creatinine concentration <1.5 mg/dl;- Patients legally able to give written informed consent to the trial (signed and dated by the patient); - Written informed consent.
- •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
- •- Uncontrolled diabetes (glycated hemoglobin >11%); - Acute cardiovascular events over the last 3 months; - Specific contraindications or history of hypersensitivity to the study drugs; - Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer; - Drug or alcohol abuse; - Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial; - Evidence of an uncooperative attitude; - Any evidence that patient will not be able to complete the trial follow-up.
研究者
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