COMbination therapy for PulmonAry hypertension using RacEcadotril (COMPARE). - Combination therapy in pulmonary hypertension

niversity College London0 个研究点目标入组 21 人开始时间: 2013年5月13日最近更新: 2019年4月30日

适应症

试验速览

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•1. WHO Group I pulmonary hypertension(i.e. idiopathic, familial or associated with connective tissue diseases) 2. 18-80 years old 3. Technically satisfactory right heart catheterisation (Step 1 only) 4. On sildenafil (20-100 mg; t.i.d.) 5. Six minute walk distance of equal to or >150 m at entry 6. No changes to PH specific therapies for 1 month 7. Not pregnant (women only). Women of childbearing potential only: Women must have a negative pregnancy test within seven days prior to being registered for trial treatment on day 0; they must be willing to use an effective method of contraception (including hormonal or barrier method of birth control) from the time consent is signed until six weeks after treatment discontinuation 8. Able to provide consent for the trial
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1. Known sensitivity to racecadotril 2. Clinical diagnosis of liver cirrhosis or ALT/AST >two times the upper limit of normal 3. Kidney disease with an eGFR of <50 ml/min 4. History of angioedema 5. Systolic blood pressure <85 mmHg 6. Known history of drug or alcohol abuse within six months of enrolment 7. Participation in a clinical study involving another investigational drug 8. Women who are breastfeeding 9. Any clinical condition for which the investigator would consider the patient unsuitable for the trial.

发起方

niversity College London