NCT02235402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 Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Changes in ß-TG (thromboglobulin)
研究概览
简要总结
The aim of this study is to compare the effects of lacidipine on markers of platelet activation and other rheological factors in hypertensive patients with those of bendrofluazide
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over
- •Hypertensive at screening: Diastolic blood pressure (DBP) 95 - 115 mm Hg and / or systolic blood pressure (SBP) >= 160 mm Hg on no therapy or on monotherapy. If currently on monotherapy, DBP could have been < 95 mm Hg and SBP < 160 mm Hg, but the patient must have been experiencing unacceptable side effects from their current treatment. Patient must then be able to stop treatment for the placebo run in phase of four weeks without endangering their health (at investigator's discretion)
- •Hypertensive at randomisation: DBP 95-115 mm Hg and or SBP >=160
- •Able to give written informed consent
排除标准
- •Grad III or grad IV hypertensive retinopathy
- •Renal impairment; serum creatinine > 150 µmol/L
- •Heart failure. (New York Heart Association (NYHA) Class III or IV)
- •Liver impairment (abnormal Liver function test (LFT) with aspartate-amino transferase (AST) / alanine-amino transferase (ALT) > 2x upper normal limit or bilirubin > 2x upper normal limit)
- •Recent (< 2 months) history of unstable angina
- •Recent (< 2 months) history of myocardial infarction
- •Recent (< 2 months) history of stroke
- •History of diabetes mellitus or impaired glucose tolerance or random blood glucose >= 9 mMol/L
- •Any acute systemic illness or infection
- •Any severe disease which could interfere with survival or well-being during the study (e.g. malignancy)
- •Patients of child bearing potential
- •Current or previous drug and / or alcohol abuse
- •Severely limited venous access
- •Haemoglobin < 10g/dL (male patients), haemoglobin < 9g/dL (female patients)
- •Requirement for anticoagulant therapy
- •Severe valvular heart disease (investigator's discretion)
- •Atrial fibrillation or other serious cardiac dysrhythmia
- •History of thyroid disease or abnormal thyroid function test (thyroid stimulating hormone (TSH) < 0.4 mU/L or > 5.4 mU/L)
- •History of connective tissue disorder
- •Concurrent participation in any other clinical trial or participation within two months enrolment
- •Requirement for restricted drugs
- •Patients currently on treatment with lacidipine or bendrofluazide (BNFZ)
- •Patients unable to attend clinics
- •Any clinical condition which in the opinion of the investigator, would preclude the safe fulfillment of the protocol and the safe administration of trial medication
- •Seated blood pressure (BP) exceeding either 210 mm Hg (systolic) or 115 mm Hg (diastolic) at screening or randomization
- •Standing BP < 140 mm Hg (systolic) and < 95 mm Hg (diastolic) at randomization
研究组 & 干预措施
Lacidipine
Experimental
干预措施: Lacidipine (Drug)
Bendrofluazide
Active Comparator
干预措施: Bendrofluazide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in ß-TG (thromboglobulin)
时间窗: Up to week 12 after drug administration
次要结局
- Changes in lipid levels between randomisation and last visit(Up to week 12 after drug administration)
- Number of patients with clinical significant findings in laboratory parameters(Up to week 12 after drug administration)
- Changes in soluble p-selectin(Up to week 12 after drug administration)
- Number of patients with adverse events(Up to week 12 after drug administration)
- Changes in rheological factors(Up to week 12 after drug administration)
研究者
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