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Hypertension, PulmonaryPhase 2NCT00694850

Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease (ILD) Associated Pulmonary Hypertension (PH)

A Phase 2 study testing Riociguat (Adempas, BAY63-2521). in people with Hypertension, Pulmonary, run by Bayer at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521) given orally, to evaluate if it is safe and can help to improve the well-being, symptoms (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung fibrosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Pulmonary
What is being tested?
Riociguat (Adempas, BAY63-2521).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
5 sitesGermany
Study dates
2 Aug 2008to 3 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of an interstitial lung disease (usual interstitial pneumonia [UIP], nonspecific interstitial pneumonia [NSIP] or sarcoidosis) with high resolution CT and a total lung capacity (TLC) ≤ 90% or scleroderma associated pulmonary arterial hypertension (PAH) with total lung capacity (TLC) ≤ 80%.
  • Interstitial lung disease (ILD) must have been stable for at least 3 months (decrease in forced vital capacity (FVC)< 10% and diffusing capacity of lung for carbon monoxide (DLco) < 15 % in 3 months), i.e. no significant changes in pulmonary function testing and stable medication in terms of ILD (e.g., corticosteroids, immunosuppressants)
  • Mean pulmonary vascular resistance (PVR) > 400 dyne sec cm-5 or mean pulmonary arterial pressure (PAP mean) > 30 mmHg
  • Pulmonary capillary wedge pressure (PCWP) < 15 mmHg
  • Hemodynamic parameters at baseline (PAP, PCWP, cardiac output [CO], systemic mean arterial pressure [SAP])
  • High resolution computer tomography (HRCT) (should not be older than 12 months prior start of the study)
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  • Heart rate > 55 beats per minute (BPM) and < 105 BPM at rest
  • Systolic blood pressure (SBP) > 90 mmHg
  • World Health Organisation (WHO) functional class II, III and IV
  • 6 Minute Walking Test (6MWT) > 100m and < 450 m
  • Stable controlled arterial hypertension according to current guidelines
  • Women of childbearing potential will be included in the study if the pregnancy test is negative and combination of condoms with a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain intra-uterine devices [IUDs]) is granted.

Who cannot join

  • Co-medication:
  • Patients pretreated with specific medication for pulmonary arterial hypertension (PAH) like endothelin receptor antagonists, prostaglandins or phosphodiesterase type 5 (PDE 5) blockers are excluded from the trial.
  • Requirement for concomitant use of nitrates are contraindicated.
  • Pre-existing clinically relevant lung disease other than ILD including.
  • Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD) with a forced expiratory volume in one second (FEV1)/FVC <60% pred., active tuberculosis
  • Pulmonary hypertension of another WHO group (I, II, IV and V)
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  • Severe congenital abnormalities of the lungs, thorax and diaphragm
  • Clinical or radiological evidence of a pulmovenoocclusive disease (PVOD)
  • Systemic hemodynamics
  • Acute or severe chronic left heart failure (ejection fraction (EF) < 50%)
  • Severe coronary artery disease (CAD; EF < 50%); CAD patients must be asymptomatic and stable
  • Congenital or acquired valvular or myocardial disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension
  • Pulmonary function
  • TLC predicted < 30%
  • FEV1 (related to FVC) < 60% predicted
  • Blood gases at room air
  • Arterial partial carbon dioxide pressure (Pa CO2) > 45 mmHg
  • Arterial partial oxygen pressure (Pa O2) < 50 mmHg at O2 supply >/= 4 L/min
  • Peripheral organ function
  • Moderate or severe hepatic insufficiency (Child-Pugh Class Band C and/or total bilirubin > 2.5 mg/dl (0.043 mmol/L); and/or hepatic transaminases >3 upper limit normal [ULN])
  • Moderate or severe renal insufficiency (creatinine > 2 mg/dl) or creatinine clearance according to Cockroft-Gault formula < 35 mL/ min

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Study site

    Dresden, Saxony, 1307

  • Study site

    Giessen, Hesse, 35392

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66421

  • Study site

    München, Bavaria, 81377

Other trials in Germany

About this study

Official title: A Multi-center, Non-randomized, Non Blinded, Non-controlled Study to Investigate the Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease Associated Pulmonary Hypertension.

The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521) given orally, to evaluate if it is safe and can help to improve the well-being, symptoms (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung fibrosis. Patients living with pulmonary hypertension associated with interstitial lung disease have a risk of increased number of hospitalisations because of worsening of their condition. Until now there is no approved medication for this disease. The current treatment of pulmonary hypertension associated with interstitial lung disease consists: of oxygen and medical treatment with vasodilators, e.g. so-called Calcium-antagonists. Therefore, there is a need for new drugs in the treatment of pulmonary hypertension associated with interstitial lung disease.

Being tested
Riociguat (Adempas, BAY63-2521).
Keywords
Interstitial lung disease associated pulmonary hypertension
Medical subject headings
Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Riociguat (Adempas, BAY63-2521).Drug

    BAY63-2521 will be up-titrated from 1,0 mg TID to 2,5 mg TID

Study groups in NCT00694850
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Riociguat (Adempas, BAY63-2521).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Measured: 12 weeks treatment

Secondary outcomes (8)

  1. Pharmacokinetics

    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014

    Measured: at every study visit except at run-in and Follow-up

  2. 6-Minute Walk Test

    Measured: at every study visit except at Follow-up

  3. Modified borg scale

    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014

    Measured: at every study visit except at Follow-up

  4. Quality of life assessments

    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014

    Measured: at baseline, after 6 weeks, after 12 weeks, Follow-up and at each visit during long term extension phase

  5. Hemodynamic parameters

    Measured: optional after 12weeks

  6. Laboratory Parameters

    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014

    Measured: at each study visit during run-in and treatment phase and long term extension

  7. Electrocardiogram (ECG)

    The assessment will be stopped after protocol amendment 4, which was effective since Jan 06, 2014

    Measured: at each study visit during run-in and treatment phase and long term extension

  8. Blood pressure and heart rate

    Measured: at each study visit during run-in and treatment phase and long term extension

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2008 (estimated)
  2. Study start2 Aug 2008
  3. Primary completion3 Jul 2025
  4. Study completion3 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00694850
Sponsor's protocol ID
12916
Other IDs
2023-507526-17-00, 2007-003928-37, 2023
Status last verified
Jul 2025
First submitted
9 Jun 2008
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Publications

  • Hoeper MM, Halank M, Wilkens H, Gunther A, Weimann G, Gebert I, Leuchte HH, Behr J. Riociguat for interstitial lung disease and pulmonary hypertension: a pilot trial. Eur Respir J. 2013 Apr;41(4):853-60. doi: 10.1183/09031936.00213911. Epub 2012 Aug 30.

    PubMed 22936711

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Riociguat (Adempas, BAY63-2521). in people with Hypertension, Pulmonary, run by Bayer at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: 12 weeks treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00694850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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