ISRCTN05051235已完成不适用
Open, prospective, parallel, multicentre, randomized trial to evaluate the efficacy and safety of two ramipril 5mg+ hydrochlorothiazide 25 mg formulations (Naprix D® versus Triatec D®) in the treatment of mild to moderate hypertension
ibbs Pharmaceutical Ltd (Brazil)0 个研究点目标入组 130 人开始时间: 2010年9月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Both sex, adults (> 18 years)
- •2. Established essential hypertension, untreated or treated but uncontrolled with treatment:
- •2.1. Office systolic blood pressure (SBP) 160-179 mmHg and diastolic blood pressure (DBP) 100-109 mmHg for untreated patients or patients already treated with combination drug
- •2.2. Office SBP 140-159 mmHg and DBP 100-109 mmHg for non-controlled patients treated with monotherapy
排除标准
- •1. Women of childbearing potential
- •2. Known hypersensitivity to drug study or angiotensin-converting enzyme inhibitors and/or diuretics
- •3. No-adhesion to treatment during run-in phase
- •4. Abnormal and clinically significant laboratory test results
- •5. Abnormal and clinically relevant ECG tracing
- •6. Pectoris Angina
- •7. Decompensate Congestive Heart Failure or that requires use of antagonists of renin-angiotesin-aldosteron system
- •8. Obesity with BMI over 35 kg/m2
- •9. Advanced or moderate hepatitis insufficiency
- •10. Decompensate or serious renal insufficiency. Creatinine clearance above 30 mL/min/1,73 m2
- •11. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease
- •12. Recent (< 6 months) or planned coronary revascularization
- •13. Cerebral vascular accident in the previous twelve months
- •14. Non controlled diabetes mellitus
- •15. Any serious or relevant disease at investigator criteria
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