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

NCT00694850 | Completed Phase 2 DMC

• 3 other identifiers: 129162023-507526-17-002007-003928-37
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Hypertension, Pulmonary

Keywords

Interstitial lung disease associated pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  12 weeks treatment

Secondary Outcomes (8)

• Pharmacokinetics

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

• 6-Minute Walk Test

  at every study visit except at Follow-up

• Modified borg scale

  at every study visit except at Follow-up

• Quality of life assessments

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

• Hemodynamic parameters

  optional after 12weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Riociguat (Adempas, BAY63-2521).

Interventions

Riociguat (Adempas, BAY63-2521). DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (5)

Unknown Facility

München, Bavaria, 81377, Germany

Location

Unknown Facility

Giessen, Hesse, 35392, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30625, Germany

Location

Unknown Facility

Homburg, Saarland, 66421, Germany

Location

Unknown Facility

Dresden, Saxony, 1307, Germany

Location

Related Publications (1)

• 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.

  PMID: 22936711 RESULT

Related Links

• Click here and search for drug information provided by the FDA.
• Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: August 2, 2008
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)