A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (PATENT-1)

November 3, 2023 updated by: Bayer

Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
445

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
      • New Lambton Heights, New South Wales, Australia, 2305
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
      • Herston, Queensland, Australia, 4029
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Prahran, Victoria, Australia, 3181
  • Austria
      • Innsbruck, Austria, 6020
      • Wien, Austria, 1090
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Leuven, Belgium, 3000
  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020 090
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 04012 180
      • São Paulo, Sao Paulo, Brazil, 04020-050
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • China
      • Beijing, China, 100020
      • Beijing, China, 100037
      • Shanghai, China, 200032
      • Shanghai, China, 200433
    • Guangdong
      • Guangzhou, Guangdong, China, 510100
  • Czechia
      • Praha 2, Czechia, 12808
  • Denmark
      • Aarhus N, Denmark, 8200
  • France
      • Besancon, France, 25030
      • Brest, France, F-29609
      • GRENOBLE Cedex 09, France, 38043
      • Lille Cedex, France, 59037
      • Montpellier, France, 34059
      • Nice, France, 06200
      • Pessac, France, 33604
      • Rouen, France, 76031
  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
    • Bayern
      • München, Bayern, Germany, 81377
    • Hessen
      • Gießen, Hessen, Germany, 35392
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50924
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04103
  • Greece
      • Chaidari, Greece, 124 62
  • Israel
      • Petah Tikva, Israel, 4941492
  • Italy
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
    • Lazio
      • Roma, Lazio, Italy, 00161
    • Lombardia
      • Milano, Lombardia, Italy, 20123
      • Pavia, Lombardia, Italy, 27100
    • Piemonte
      • Torino, Piemonte, Italy, 10043
  • Japan
      • Hiroshima, Japan, 734-8551
      • Okayama, Japan, 701-1192
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
    • Fukui
      • Yoshida, Fukui, Japan, 910-1193
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
    • Ibaraki
      • Toride, Ibaraki, Japan, 302-0022
      • Tsukuba, Ibaraki, Japan, 305-8576
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Okinawa
      • Tomigusuku, Okinawa, Japan, 901-0243
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Mitaka, Tokyo, Japan, 181-8611
      • Ota-ku, Tokyo, Japan, 143-8541
      • Shinjuku-ku, Tokyo, Japan, 160-8582
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 06351
      • Seoul, Korea, Republic of, 03722
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
  • Mexico
      • Mexico D.F., Mexico, 14080
      • Querétaro, Mexico, 38000
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
      • Guadalajara, Jalisco, Mexico, 44670
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64020
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
  • New Zealand
      • Christchurch, New Zealand, 8011
  • Poland
      • Otwock, Poland, 05-400
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1169-024
      • Porto, Portugal, 4099-001
  • Russian Federation
      • Moscow, Russian Federation, 121552
      • St. Petersburg, Russian Federation, 197341
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 168752
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Sevilla, Spain, 41013
  • Sweden
      • Linköping, Sweden, 581 85
      • Lund, Sweden, 221 85
      • Umeå, Sweden, 901 85
  • Switzerland
      • Zürich, Switzerland, 8091
  • Taiwan
      • Kaohsiung City, Taiwan, 813414
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 11217
  • Thailand
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
  • Turkey
      • Ankara, Turkey
      • Istanbul, Turkey, 34098
      • Izmir, Turkey, 35-100
  • United Kingdom
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, W12 0HS
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
    • West Dunbartonshire
      • Clydebank, West Dunbartonshire, United Kingdom, G81 4DY
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90073
      • Sacramento, California, United States, 95817
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02115
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New York
      • New York, New York, United States, 10032
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43221
      • Fairfield, Ohio, United States, 45014
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
    • Texas
      • Dallas, Texas, United States, 75390
      • El Paso, Texas, United States, 79902
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
  • Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).

Exclusion Criteria:

  • All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Experimental: Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT
Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
Placebo Comparator: Placebo
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
Drug: Placebo
Matching Placebo tid orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
Time Frame: Baseline and week 12
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
Baseline and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12
Time Frame: Baseline and week 12
The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO
Baseline and week 12
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12
Time Frame: Baseline and week 12
N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Baseline and week 12
World Health Organization (WHO) Functional Class - Change From Baseline to Week 12
Time Frame: Baseline and week 12
The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.
Baseline and week 12
Percentage of Participants With Clinical Worsening
Time Frame: At week 12
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .
At week 12
Borg CR 10 Scale - Change From Baseline to Week 12
Time Frame: Baseline and week 12
The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
Baseline and week 12
EQ-5D Utility Score - Change From Baseline to Week 12
Time Frame: Baseline and week 12
EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).
Baseline and week 12
Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12
Time Frame: Baseline and week 12
The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2008

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12934
  • 2008-003482-68 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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