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 | |
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Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80539 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bron, France, 69500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13915 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE CEDEX, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Darlinghurst, Australia, 2010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chermside, Australia, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camperdown, Australia, 2050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prahran, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Murdoch, Australia, 6150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Falls Church, United States, 22042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, Los Angeles Los Angeles, United States, 90024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbia University Medical Center New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Via Christi Clinic Wichita, United States, 67208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232-5735 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75235-3858 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 15, France, 75908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza-Brianza, Italy, 20900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Forlì-Cesena, Italy, 47121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW3 6NP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clydebank, United Kingdom, G81 4DY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1Y 4W7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 1M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genève, Switzerland, 1205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seto, Japan, 489-8642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakai, Japan, 591-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 236-0051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shibuya-ku, Japan, 151-8528 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1V 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sydney, Australia, 2751 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grosshansdorf, Germany, 22927 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, 4200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vila Nova de Gaia, Portugal, 4434-502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Christchurch, New Zealand, 8011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 1051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, 1426 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mar del Plata, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Godoy Cruz, Argentina, 5501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Miguel de Tucumán, Argentina, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Floridablanca-Bucaramanga, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cali, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haidari, Greece, 12462 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Thessaloniki, Greece, 570 10 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ioannina, Greece, 45500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 91120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11525 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11461 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orlando, United States, 32803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 105077 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 107564 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vladimir, Russia, 600023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45219 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santafe de Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denizli, Turkey, 20070 | 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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