A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 10
- 主要终点
- Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.
详细描述
To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form.
Some eligibility criteria:
perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure between 140 mmHg - 159 mmHg
- •Diastolic blood pressure between 90 mmHg - 99 mmHg
- •Subject aged ≥ 60 years old
- •Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project.
- •Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration.
排除标准
- •Any serious or severe clinically significant medical condition.
- •Psychiatric or neurological diseases
- •A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient.
- •Participation in any other investigational study within 12 months prior to Visit
- •Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study
- •Routine prior use of diuretics
- •Oral anticoagulant use
- •Fast glycemia > 150 mg/dL
- •Medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up.
- •Expected onset of additional antihypertensive drug after the study onset
- •Acute myocardial infarction within last 6 months
- •Prior decompensated coronary artery disease
- •Known thyroid, renal or liver dysfunction, at investigator's discretion
- •Obesity - body mass index (BMI) > 33 kg/m2
研究组 & 干预措施
Higroton®
Chlorthalidone 25mg - one oral tablet a day in the morning
干预措施: Higroton® Laboratório Novartis (Drug)
Diupress®
Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
干预措施: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Drug)
结局指标
主要结局
Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4
时间窗: Visit 4 (75 ± 3 days of V1)
V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)
次要结局
- Blood Pressure(Visit 4 (75 ± 3 days of V1))