Trial Condition(s):
Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
Efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) (RISE-IIP)
Bayer Identifier:
13605
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
Inclusion Criteria
- Men or women aged from ≥18 to ≤80 years
- Diagnosed with one of the following (confirmed using a multidisciplinary approach, as per ATS(American Thoracic Society) / ERS(European Respiratory Society) / JRS (Japanese Respiratory Society) / ALAT(Latin American Thoracic Association) guidelines:
-- Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following:
-- Idiopathic pulmonary fibrosis
-- Idiopathic nonspecific interstitial pneumonia
-- Respiratory bronchiolitis–interstitial lung disease
-- Desquamative interstitial pneumonia
-- Cryptogenic organizing pneumonia
-- Acute interstitial pneumonia
-- Rare IIPs diagnosis by one of the following:
-- Idiopathic lymphoid interstitial pneumonia
-- Idiopathic pleuroparenchymal fibroelastosis
-- Unclassifiable idiopathic interstitial pneumonias
- Forced Vital Capacity (FVC) ≥ 45 %
- 6MWD (6 minutes walking distance) ≥ 150 m to ≤ 450 m {under stable O2(oxygen) supplementation via nasal cannula}
- Diagnosis of PH (pulmonary hypertension) confirmed by right heart catheter (RHC) with (mean artery pulmonary artery pressure )mPAP ≥ 25 mmHg and (pulmonary artery wedge pressure)PAWP ≤15 mmHg at rest
- Systolic blood pressure (SBP) ≥ 95 mmHg and no signs or symptoms of hypotension
- WHO functional class II-IV
- Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contraception when sexually active. ‘Adequate contraception’ is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Adequate contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration
-Exclusion Criteria
- Known significant left heart disease: -- Pulmonary venous hypertension indicated by baseline pulmonary capillary wedge pressure > 15 mmHg -- Symptomatic coronary artery disease -- Systolic left-ventricular dysfunction with an left ventricular ejection fraction (LVEF) <45% - Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization - Any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening. Massive hemoptysis being defined as acute bleeding >240 mL in a 24-hour period or recurrent bleeding >100 mL/d over several days - Difference > 15% between the eligibility and the baseline 6MWD test - Forced expiratory volume in one second (FEV1) / Forced Vital Capacity (FVC) <0.65 after bronchodilator administration - Initiation in cytotoxic, immunosuppressive, cytokine modulating therapy initiated within 3 months prior to screening. Such agents might include. azathioprine, cyclophosphamide, corticosteroids, etanercept, tumor necrosis factor alpha (TNFα) inhibitors and others - Any specific treatment for (pulmonary arterial hypertension) PAH/PH (pulmonary hypertension )within 3 months prior to screening - Concomitant use of the following medication: nitrates or (nitric oxide) NO donors (such as amyl nitrite) in any form, phosphodiesterase 5 inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific phosphodiesterase (PDE) inhibitors (theophylline, dipyridamole), - Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women of childbearing potential not using adequate contraception (as defined in the aforementioned inclusion criterion) and not willing to agree to 4 weekly pregnancy testing from Visit 1(first administration of study drug) onwards until 4 weeks after last study drug intake
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80539 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bron, France, 69500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13915 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE CEDEX, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Darlinghurst, Australia, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chermside, Australia, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camperdown, Australia, 2050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prahran, Australia, 3181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Murdoch, Australia, 6150 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Falls Church, United States, 22042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, Los Angeles Los Angeles, United States, 90024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbia University Medical Center New York, United States, 10032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Via Christi Clinic Wichita, United States, 67208 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232-5735 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75235-3858 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 15, France, 75908 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza-Brianza, Italy, 20900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Forlì-Cesena, Italy, 47121 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW3 6NP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clydebank, United Kingdom, G81 4DY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle, United Kingdom, NE7 7DN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1Y 4W7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 1M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genève, Switzerland, 1205 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seto, Japan, 489-8642 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakai, Japan, 591-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8677 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 236-0051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shibuya-ku, Japan, 151-8528 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1V 4G5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sydney, Australia, 2751 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grosshansdorf, Germany, 22927 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gießen, Germany, 35392 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43221 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, 4200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vila Nova de Gaia, Portugal, 4434-502 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Christchurch, New Zealand, 8011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 1051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus N, Denmark, 8200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, 1426 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mar del Plata, Argentina | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Godoy Cruz, Argentina, 5501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Miguel de Tucumán, Argentina, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Floridablanca-Bucaramanga, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cali, Colombia | Status Terminated | Contact Us: E-mail: [email protected]er.com Phone: Not Available |
Locations Investigative Site Haidari, Greece, 12462 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Thessaloniki, Greece, 570 10 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ioannina, Greece, 45500 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 91120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11525 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11211 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11461 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40202 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orlando, United States, 32803 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 105077 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 107564 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vladimir, Russia, 600023 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45219 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santafe de Bogotá, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denizli, Turkey, 20070 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, placebo-controlled phase II study to investigate the efficacy and safety of riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (IIP).
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Mean change in 6 minute walking distance (6MWD) from baseline to week 26The 6MWD test is designed to evaluate a patient’s exercise capacity while performing an everyday activity.Timeframe: Baseline to 26 weeks
Secondary Outcome
- Number of participants with clinical worseningThe combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class.Timeframe: From baseline to week 26
Additional Information
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