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Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)

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ClinicalTrials.gov Identifier: NCT02825160
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This study is collecting post-marketing information on the safety and effectiveness of Ventavis under the routine clinical practice for patients with PAH

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Ventavis (Iloprost, BAYQ6256)

Detailed Description:

This local, prospective, non-interventional, company sponsored, multi-center, single-cohort study includes patients treated with Ventavis for PAH. A total of 270 patients (valid for safety analysis) is planned to be enrolled in 5 years. Target population is patients with PAH diagnosis. This study is performed as an all-patient investigation, therefore all patients who receive Ventavis treatment for PAH need to be registered. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Ventavis treatment. In addition, the extension observation will be carried out as long as Ventavis treatment continues or at most for more 4 years. The standard observation points are 3 month and

1 to 5 years.


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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 27, 2023


Group/Cohort Intervention/treatment
Ventavis
Ventavis treatment group
Drug: Ventavis (Iloprost, BAYQ6256)
The treatment of Ventavis should comply with the local product information




Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events (TEAE) of special interest. [ Time Frame: Up to 5 years ]

    TEAE of special interest:

    • Hypotension
    • Syncope
    • Local irritation
    • Bleeding events
    • Thrombocytopenia
    • Tachycardia

  2. Number of participants with adverse drug reaction [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months, ]
  2. Change from baseline in 6-Minute Walking Distance after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  3. Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  4. Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months. [ Time Frame: Baseline and 3 months,Baseline and 12 months ]
  5. Change from baseline in WHO functional class after 3 and 12 months [ Time Frame: Baseline and 3 months,Baseline and 12 months, ]
  6. Time to Clinical Worsening [ Time Frame: Up to 5 years ]

    The 1st occurrence date of one of the following events is recorded and used for the calculation of time to clinical worsening:

    • Death (all-cause mortality), -Heart/lung transplantation, -Atrial Septostomy,
    • Hospitalization due to persistent worsening of Pulmonary Hypertension (PH),
    • Start of new PH specific treatment or modification of a preexisting Prostacycline analogues treatment except Ventavis due to worsening PH,
    • Persistent decrease in 6MWD due to worsening PH,
    • Persistent worsening of WHO functional class due to deterioration of PH



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population includes PAH patients treated with Ventavis. This study is performed as an all-case investigation. Therefore, all patients who have been treated with Ventavis for PAH need to be registered in principle, until the target number of patients reached.
Criteria

Inclusion Criteria:

  • Patients diagnosed with PAH
  • Patients for whom the decision to initiate treatment with Ventavis was made as per investigator's routine treatment practice.

Exclusion Criteria:

- N/A


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825160


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Japan
Many Locations Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02825160     History of Changes
Other Study ID Numbers: 17941
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by Bayer:
Iloprost
Ventavis
Prostacycline analogue
Pulmonary arterial hypertension
Japan
Post-marketing surveillance
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents