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NCT Number: NCT02117791

Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )

This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are treated with Riociguat for CTEPH

Exclusion criteria

  • Patients who are contraindicated based on the product label

Treatment and study plan

Riociguat (Adempas, BAY63-2521)

Drug

The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)

Primary outcomes

  1. Number of participants with treatment emergent adverse events and adverse drug reactions

    Time frame: up to 8 years

Secondary outcomes

  1. Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months

    Time frame: baseline and 4 months, and 12 months

  2. Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months

    Time frame: baseline and 4 months, and 12 months

  3. Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months

    Time frame: baseline and 4 months, and 12 months

  4. Change from baseline in BNP/NT-pro BNP after 4 and 12 months

    Time frame: baseline and 4 months, and 12 months

  5. Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months

    Time frame: baseline and 4 months, and 12 months

  6. Time to Clinical Worsening

    Time frame: up to 8 years

    The first occurrence of the following events is recorded and will be considered for the calculation of the combined endpoint: • Death (all-cause mortality) • Heart/lung transplantation • Rescue Pulmonary Endarterectomy, Rescue Balloon Pulmonary Angioplasty or Hospitalization due to persistent worsening of Pulmonary Hypertension • Start of new PH specific treatment due to worsening Pulmonary Hypertension. • Persistent decrease in 6MWD due to worsening pulmonary hypertension • Persistent worsening of functional class due to deterioration of Pulmonary Hypertension.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)

Acronym: JPMS-CTEPH

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2014
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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