NCT05110898Unknown3 期
Randomized, Single-Blind, Multicenter, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
Brainfarma Industria Química e Farmacêutica S/A0 个研究点目标入组 400 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 主要终点
- Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
研究概览
简要总结
Phase III clinical trial, multicenter of non-inferiority, randomized, single-blind evaluation of fixed-dose combination of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
详细描述
This study is designed for the treatment of essential hypertension. It is performed in participants of both sexes, over 18 years of age, who have essential hypertension with diastolic blood pressure between 90 mmHg and 110 mmHg.
The rationale for studying the fixed dose combination is the possibility to enhance compliance and simplify treatment.
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
- Single (Investigator)
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
- •Have signed the informed consent form;
- •Participants of both genders aged ≥ 18 years;
- •Essential hypertension based on a Diastolic Blood Pressure (DBP) > 90 mmHg and < 110 mmHg;
- •Patients with no treatment or on antihypertensive therapy taking up to two anti-hypertensives;
- •Possibility of discontinuing previous antihypertensive medication during the washout period.
排除标准
- •Essential hypertension based on a Diastolic Blood Pressure (DBP) ≥ 110mmHg and Systolic Blood Pressure (SBP) ≥ 180 mmHg;
- •Secondary hypertension;
- •Participants with Body Mass Index (BMI) > 35 Kg/m2;
- •Non-controlled types 1 and 2 diabetes mellitus (HbA1 > 8,5%);
- •Myocardial infarction, coronary surgery or coronary angioplasty with or without stent placement, in the last 6 months;
- •Unstable angina;
- •Participants with coronary heart disease taking beta-blockers;
- •Clinically manifest heart failure;
- •History of cardiac arrhythmia;
- •Moderate and severe heart valve disease;
- •Stroke or transient ischemic attack in the last 6 months;
- •Chronic disease of any nature that contraindicates the participant's participation according to the investigator's judgment, in particular renal failure with glomerular filtration rate < 45 ml/min, serum potassium levels ≥ 5,5 mEq/L or ≤ 3,5 mEq/L, hepatopathies, or SGOT, SGPT or bilirubin levels 3 times above the normal upper limit, and blood dyscrasias;
- •Known allergies or contraindication to the use of the study medication components;
- •Female participants who are pregnant, breastfeeding or who want to become pregnant;
- •COVID-19 symptoms;
- •Post COVID-19 syndrome with cardiovascular impairment;
- •Subjects who have participated in other study within the 12 months prior to screening (unless benefit is justified by the researcher).
研究组 & 干预措施
Fixed-dose Olmesartan 20mg/40 mg + Indapamide 1,5 mg
Experimental
干预措施: fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg (Drug)
Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
Active Comparator
干预措施: Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg) (Drug)
结局指标
主要结局
Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension.
时间窗: 12 weeks of treatment
To evaluate the non-inferiority of the fixed dose association of olmesartan + indapamide to the isolated drugs in the change of the diastolic blood pressure from baseline to 12 week endpoint through Ambulatory Blood Pressure Monitoring.
次要结局
- Diastolic Blood Pressure Control(12 weeks of treatment)
- Proportion of systolic and diastolic treatment response(12 weeks of treatment)
- Systolic Blood Pressure Control(12 weeks of treatment)
- Patients responses to the treatment satisfaction questionnaire(12 weeks of treatment)
- Tolerability and occurrence of adverse events (AEs) during the study period.(12 weeks of treatment)
- Systolic and diastolic blood pressure variation by ABPM exam(12 weeks of treatment)
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