Racecadotril used in combination with sildenafil to reduce blood pressure in the lungs.

Phase 1

• Conditions: Pulmonary hypertension; MedDRA version: 14.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003921-13-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-13
• Study Completion: 2017-04-05
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified