NCT02177331已完成3 期
Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions During Long-term Treatment. 3rd Follow-up Study - Long-term Use in the 4th and 5th Year Treatment Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Number of patients with rare adverse drug reactions
研究概览
简要总结
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of entry criteria for the preceding yearly study
- •Male or female patients aged between 20 and 85 years
- •Known history of mild to moderate essential hypertension requiring drug treatment, WHO grade I to II
- •Controlled blood pressure (RR diastolic ≤ 90 mm Hg or 91 - 95 mm Hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
- •Final visit of the previous yearly study (Visit 4) completed as scheduled
- •Informed consent to participate in the follow-up study
排除标准
- •Violation of entry/exclusion criteria on enrolment in the preceding yearly study
- •Occurrence of the following exclusion criteria in the intervening period:
- •Pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
- •Secondary form of hypertension
- •Consumptive illness
- •Clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (NYHA Class III or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
- •Myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
- •Hypersensitivity to dihydropyridines
- •Concomitant long-term treatment (> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
- •Suspected alcohol, narcotic or drug abuse
研究组 & 干预措施
Lacidipine
Experimental
干预措施: Lacidipine (Drug)
结局指标
主要结局
Number of patients with rare adverse drug reactions
时间窗: up to 24 months
Change in alkaline phosphatase (AP)
时间窗: up to 24 months
Change in serum glutamic - pyruvic transaminase (SGPT)
时间窗: up to 24 months
次要结局
- Changes in systolic and diastolic blood pressure(up to 24 months)
- Change in serum glutamic - oxaloacetic transaminase (SGOT)(up to 24 months)
- Number of patients with abnormal changes in laboratory parameters(up to 24 months)
- Changes in gamma glutamyl transferase (gamma-GT)(up to 24 month)
研究者
相似试验
已完成
2 期
Efficacy and Safety of Lacidipine in Chronic Stable AnginaAngina PectorisNCT02232607Boehringer Ingelheim283
已完成
1 期
Effects of Cladribine Tablets on the PK of Microgynon®Relapsing Multiple Sclerosis (RMS)NCT03745144Merck KGaA, Darmstadt, Germany28
已完成
4 期
A Randomised, Parallel-group, Double-blind, Double-dummy Study to Compare the Effects of Lacidipine Versus Bendrofluazide on Markers of Platelet Activation and Haemorheological Factors in Hypertensive PatientsHypertensionNCT02235402Boehringer Ingelheim26
已完成
2 期
Pediatric Epilepsy Trial in Subjects 1-24 MonthsEpilepsyNCT00043875GlaxoSmithKline177
已完成
4 期
Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 YearsHypertensionNCT00460915Korea University Guro Hospital204