This Study Tests the Safety of Inhaled BAY1237592 How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

  • STATUS
    Recruiting
  • End date
    Jan 10, 2022
  • participants needed
    60
  • sponsor
    Bayer
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Updated on 4 February 2021
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nitric oxide
prostaglandin
pulmonary arterial hypertension
right heart catheterization
endothelin
iloprost
chronic thromboembolic pulmonary hypertension
endothelin receptor antagonist

Summary

In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure affecting the blood vessels in the lungs due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses

In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B patients stably pretreated with specific PH drugs will be studied in combination with the new inhaled drug

Details
Condition Pulmonary Hypertension, Cancer Prevention, Surviving Abuse, Joint Injuries, Abdominal Surgery, Mental Disability, Pelvic Adhesions, Low Testosterone, Dental Filling, Habit Reversal, Complicated Grief, Chronic Pelvic Pain, Gambling Problems, Myopic Macular Degeneration, Nerve Injury, Severe Premenstrual Symptom, Stasis Dermatitis, Pulmonary Arterial Hypertension, Open Heart Surgery, Recurrent Pregnancy Loss, Effects of Chemotherapy, Renal Anemia, Functional Dyspepsia, Catheter Complications, Serial Evaluation of Ductal Epithelium, Chronic Renal Anemia, Cancer Treatment, Anemic Cancer, Spinocerebellar Disorders, Pseudobulbar Affect, Spine Athroplasty, Indikation: Diabetes - Typ II, Partial Medial Meniscectomy, Primary Insulin Hypersecretion, Testotoxikose, Infantile Fibrosarcoma, Late Infantile Neuronal Ceroid Lipfuscinsosis, Memory Problems
Treatment BAY1237592, NO gas, PH-monotherapy, PH-combination therapy
Clinical Study IdentifierNCT03754660
SponsorBayer
Last Modified on4 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Habit Reversal or Cancer Treatment or Abdominal Surgery or Primary Insulin Hypersecretion or Memory Problems or Pulmonary Arterial Hypertension or Men...?
Do you have any of these conditions: Testotoxikose or Primary Insulin Hypersecretion or Dental Filling or Serial Evaluation of Ductal Epithelium or Cancer Prevention or Pulmonary Arterial...?
Do you have any of these conditions: Memory Problems or Joint Injuries or Late Infantile Neuronal Ceroid Lipfuscinsosis or Cancer Prevention or Mental Disability or Anemic Cancer or Habit...?
Do you have any of these conditions: Chronic Pelvic Pain or Memory Problems or Stasis Dermatitis or Pseudobulbar Affect or Mental Disability or Renal Anemia or Effects of Chemotherapy or ...?
Do you have any of these conditions: Complicated Grief or Infantile Fibrosarcoma or Dental Filling or Renal Anemia or Indikation: Diabetes - Typ II or Catheter Complications or Late Infan...?
Do you have any of these conditions: Low Testosterone or Pulmonary Arterial Hypertension or Severe Premenstrual Symptom or Open Heart Surgery or Nerve Injury or Spinocerebellar Disorders ...?
Do you have any of these conditions: Myopic Macular Degeneration or Pulmonary Arterial Hypertension or Recurrent Pregnancy Loss or Renal Anemia or Mental Disability or Complicated Grief o...?
Patients with PAH or CTEPH undergoing medically indicated routine invasive diagnostics
Men and women aged 18 to 80 years
Part A
Untreated patients: Therapy-naive patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sGC stimulators/activators with PAH or CTEPH or patients pretreated with approved or specific medication for PH like endothelin antagonists, prostanoids, phosphodiesterase type 5 inhibitor (PDE5 I) or soluble guanylate cyclase (sGC) stimulators who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 hours prior to Day -1 if medically safe
Part B
Untreated patients with PAH or CTEPH
\-- Group 1 (total will be summed up with corresponding dosage group from Part
A)
Pre-treated patients with PAH or CTEPH
Group 2: Pre-treated patients with any kind of monotherapy for PAH/CTEPH
Group 3: Pre-treated patients with any kind of double combination therapy for PAH/CTEPH patients receiving inhaled Iloprost, and patients who are known responders to iNO are excluded

Exclusion Criteria

Medical history indicating a different cause for PH than PAH or CTEPH according to the guidelines of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), such as significant left heart disease, valvular disease, or structural heart defects, as assessed by the investigator, significant pulmonary disease or clinical suspicion of pulmonary venoocclusive disease
History of or current possible or verified COVID-19 infection
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nitric oxide
prostaglandin
pulmonary arterial hypertension
right heart catheterization
endothelin
iloprost
chronic thromboembolic pulmonary hypertension
endothelin receptor antagonist

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