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Endothelin Receptor Antagonist
Opsumit for Interstitial Lung Disease (CRUSADE Trial)
Phase 2 & 3
Waitlist Available
Led By Franz P. Rischard, DO
Research Sponsored by Franz Rischard, DO
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
CRUSADE Trial Summary
Patients with interstitial lung disease (ILD) and scleroderma who develop pulmonary hypertension (PH) do not fit well into the current classification system and treatments for pulmonary hypertension. This study aims to better understand patients with ILD-PH and scleroderma and to determine if treatment with Macitentan is beneficial.
Eligible Conditions
- Interstitial Lung Disease
- Scleroderma
- Pulmonary Hypertension
CRUSADE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in exercise pulmonary vascular resistance (PVR)
Secondary outcome measures
Change in maximal oxygen consumption (V02 max).
Change in pulmonary impedance.
Change in right ventricular pulmonary vascular hemodynamic coupling (RVPA).
Side effects data
From 2019 Phase 4 trial • 89 Patients • NCT0231067222%
Oedema Peripheral
21%
Headache
14%
Dizziness
11%
Haemoglobin Decreased
11%
Upper Respiratory Tract Infection
11%
Cough
10%
Myalgia
9%
Diarrhoea
9%
Nasal Congestion
8%
Back Pain
8%
Pyrexia
7%
Pain in Extremity
7%
Nasopharyngitis
7%
Nausea
6%
Flushing
3%
Pneumonia
2%
Pulmonary Embolism
2%
Pulmonary Arterial Hypertension
2%
Sepsis
2%
Acute Myocardial Infarction
1%
Cytomegalovirus Infection
1%
Cholangitis Infective
1%
Herpes Zoster
1%
Hypersensitivity
1%
Therapeutic Response Decreased
1%
Escherichia Bacteraemia
1%
Epistaxis
1%
Urinary Tract Infection
1%
Hypoglycaemia
1%
Rheumatoid Arthritis
1%
Pancreatic Carcinoma
1%
Systemic Lupus Erythematosus
1%
Syncope
1%
Acute Kidney Injury
1%
Dysfunctional Uterine Bleeding
1%
Anaemia
1%
Haemolytic Anaemia
1%
Iron Deficiency Anaemia
1%
Angina Pectoris
1%
Atrial Fibrillation
1%
Cardiac Arrest
1%
Coronary Artery Disease
1%
Right Ventricular Failure
1%
Ventricular Hypokinesia
1%
Rectal Haemorrhage
1%
Dysmenorrhoea
1%
Menorrhagia
1%
Pelvic Haemorrhage
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Macitentan 10 mg
CRUSADE Trial Design
1Treatment groups
Experimental Treatment
Group I: OpsumitExperimental Treatment1 Intervention
Opsumit 10 mg tablet by mouth once daily
Find a Location
Who is running the clinical trial?
Franz Rischard, DOLead Sponsor
National Jewish HealthOTHER
140 Previous Clinical Trials
316,210 Total Patients Enrolled
University of PittsburghOTHER
1,719 Previous Clinical Trials
16,342,315 Total Patients Enrolled
Frequently Asked Questions
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