CTRI/2010/091/001389招募中2 期
Phase-2 comparative clinical trial to assess the efficacy and safety of sodium nitrite inhalation in treatment of secondary pulmonary hypertension & hypoxemic conditions
Defence R&D Organisation0 个研究点目标入组 158 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
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
入选标准
- •a) Healthy volunteers
- •1. Healthy Males/females, between 18-45 years ages group
- •2. On no permanent treatment
- •3. Suffering from no permanent / recurrent / chronic disease or disability
- •b) Diseased subjects
- •1. Worked up adult patients with pulmonary hypertension with associated hypoxemia, mild or moderate asthma or COPD or ILD with hypoxemia.
- •2. Stable treatment and symptoms history
- •3. Age group: 18-65 years
- •4. Ambulatory, preferably admitted or confined patients for better follow up
- •5. Non-critically ill patients
- •6. No need to stop medication
排除标准
- •a)Healthy volunteers
- •1. Those who do not sign the ICF
- •2. Those who have had any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial or who cannot inhale properly
- •3. Patients who have received any other investigational drug for the last 1 month.
- •4. Too low or too high body weight (< 40 kg, > 100 kg)
- •5. Pregnant & lactating women
- •b) Diseased subjects
- •1. Patients with prior hypersensitivity to nitrates
- •2. Patients who are unwilling to give informed consent.
- •3. Patients receiving oral or systemic nitric acid donors or known to have increased indigenous nitric oxide production within 4 weeks of the start of the study.
- •4. Patients on continuous oxygen
- •5. Volunteers with serious or critical illness.
- •6. Patients who are pregnant, lactating or women of child bearing potential not using medically accepted methods of contraception.
- •7. Patients with clinically significant renal, respiratory (other than those mentioned), cardiac (including rheumatic or congenital heart disease), gastrointestinal, hepatic, endocrine or hematological disorders.
- •8. Patients who have any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial.
- •9. Patients who have received any other investigational drug for the last 1 month
研究者
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