Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007265

Trial Description

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Title

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).

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Trial Acronym

13605RISE-IIP

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URL of the Trial

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007265
  •   2016/02/26
  •   2014/04/15
  •   no
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Secondary IDs

  •   2010-024332-42 
  •   NCT02138825  (ClinicalTrials.gov)
  •   13605  (Bayer)
  •   2010-024332-42 
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Health Condition or Problem studied

  •   Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
  •   J84.1 -  Other interstitial pulmonary diseases with fibrosis
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Interventions/Observational Groups

  •   Drug: Adempas, Riociguat (BAY63-2521)
  •   Device: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- The mean change in 6 minute walking distance; time frame: Baseline to 26 weeks

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Secondary Outcome

- Time to clinical worsening is a composite endpoint. The composite is made up of 4 components - Time to all-cause mortality, - Time to worsening of WHO FC, - Time to 15% decrease in 6MWD, - Time to hospitalization; time frame: Up to week 26
- Number of participants with adverse events as a measure of safety and tolerability; time frame: 8 years

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Countries of Recruitment

  •   United States
  •   Australia
  •   Belgium
  •   Canada
  •   France
  •   Germany
  •   Italy
  •   Japan
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/06/30
  •   120
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional 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

-

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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 or change 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 (TNF╬▒) 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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer Clinical Trials Contact 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.