2024-511312-24-00招募中2 期
Peripheral Edema Resolution evaluated in patients switched from amlodipine to Levamlodipine (PERLA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Zentiva k.s.
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- • Change from baseline to end of Period 2 visit of AFV by the water displacement method.
研究概览
简要总结
The primary objective will be evaluation of the peripheral edema in both legs. To determine the most effective method for this trial, peripheral edema will be measured using various techniques, applied to both legs. This will encompass both objective and subjective assessment methods, which will then be compared to the patients' reported severity and tolerability of peripheral edema.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients willing to participate the trial and sign informed consent
- •Age 18 - 79 years
- •Arterial hypertension in subjects who are controlled (SBP < 140 mm Hg and DBP < 90 mm Hg ) on 1 - 3 antihypertensive drugs including amlodipine at 10 mg or 5 mg dose for at least 1 month
- •Patients willing to complete the patient reported questionnaire
- •Patients with peripheral edema, highly suspected of calcium channel blockers (CCB) origin, visually assessed and graded as (2) moderate or (3) severe edema by the investigator AND/OR Patients who claim unacceptability of long-term treatment with amlodipine based on the answers of question 7 of the patient reported questionnaire
- •Women of child-bearing potential must be willing to use a highly effective form of birth control (confirmed by the investigator) throughout the trial or must be post-menopausal for at least 12 months or must be surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy)
排除标准
- •Inadequately controlled diabetes.
- •Patients with contraindications for amlodipine: • Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in amlodipine summary of product characteristics (SmPC; Microcrystalline cellulose [E 460a], Calcium hydrogen phosphate, Sodium starch glycolate, Magnesium stearate [E 470B]). • Severe hypotension. • Shock (including cardiogenic shock). • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis). • Hemodynamically unstable heart failure after acute myocardial infarction.
- •Patients with any other medical condition or concomitant medication that, in the opinion of the investigator, may interfere with the trial objectives or pose a risk to the patient's safety. Drugs that may cause peripheral edema: • Continuous use of nonsteroidal anti-inflammatory drugs (NSAIDs). On-demand NSAID use is acceptable but must be documented as concomitant medication. • Corticosteroids. • Antipsychotics (such as olanzapine, risperidone, quetiapine). • Anticonvulsant medications (such as pregabalin and gabapentin). • Nonselective monoamine oxidase inhibitors (MAOIs). • Nonselective vasodilators (such as minoxidil and hydralazine). • Antineoplastics, hormones and cytokines. • Immunosuppressants (such as ciclosporin, everolimus). • Opioids (such as fentanyl, morphine, tramadol).
- •Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
- •Breastfeeding, or lactating women.
- •Concurrent enrolment in another interventional clinical trial or participation in any clinical trial within the last 30 days or five half-lives of the trial drug, which ever is longer, prior to screening.
- •Treatment with CCB other than amlodipine within 1 month before screening visit.
- •Elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) without symptoms, or increase in alkaline phosphatase (ALP) > 2 times the ULN, or rise in bilirubin > 2 times the ULN in bilirubin with any increase in AST and ALT. Alternatively, also increase in AST or ALT < 5 ULN with symptoms.
- •Taking more than 3 different antihypertensive agents.
- •Documented cardiovascular event during last 12 months.
- •Atrial fibrillation or other malignant arrhythmias.
- •Severe cerebrovascular, renal, hepatic or pancreatic disease.
结局指标
主要结局
• Change from baseline to end of Period 2 visit of AFV by the water displacement method.
• Change from baseline to end of Period 2 visit of AFV by the water displacement method.
次要结局
- Efficasy: • Change from baseline to end of Period 1 and 3 visit of AFV by the water displacement.
- Efficasy: • Change from baseline to end of Period 1 (2, 3) visit of the ankle circumference by figure-of-eight method.
- Efficasy: • Semiquantitative edema scoring in both feet by the investigator at each visit.
- Efficasy: • Patient reported questionnaire.
- Additional endpoints: • Number of IMP taken and reported in patient’s diary.
- Additional endpoints: • Total number (count) of returned IMP.
- Safety: • Vital signs (SBP, DBP, heart rate, body temperature), and physical examination at each trial visit
- Safety: • Incidence of AEs during the entire trial
- Safety: • Laboratory examination (on screening visit)
研究者
Clinical Development Manager
Scientific
Zentiva k.s.
研究点 (2)
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