Study to investigate safety, tolerability, pharmacodynamics and pharmacokinetic properties of BAY 63-2521 after dosing of a 2 mg tablet in 20 patients with Raynaud’s phenomenon (RP)

Single dose, double-blind, placebo-controlled, single center, randomized cross-over study to investigate safety, tolerability, pharmacodynamics and pharmacokinetic properties of BAY 63-2521 after oral dosing of a 2 mg IR tablet in 20 patients with Raynaud’s phenomenon (RP) - DIGital flow enhancement in Raynaud’s disease with an sGC stImulaTor (DIGIT)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001899-38-DE

Enrollment

Unknown

Registered

2013-07-30

Start date

2013-07-29

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with 1° and 2° Raynaud’s phenomenon (RP) MedDRA version: 16.0 Level: PT Classification code 10037912 Term: Raynaud's phenomenon System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients suffering from Raynaud’s phenomenon with symptoms present for at least =1 year before screening. Raynaud’s phenomenon may be of the following origin: - idiopathic (primary) - undifferentiated form of scleroderma (SSc) - limited cutaneous SSc - diffuse cutaneous SSc - SSc overlap syndrome Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients taking medication interfering with the digital flow measurement such as CCB, PDE5I, ERA, Nitrates • Smokers • SBP below 105mmHg at rest

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to investigate the safety, tolerability and pharmacodynamics of a single oral dose of BAY 63-2521 administered in patients suffering from Raynaud’s phenomenon;Secondary Objective: The secondary objective of this study is to investigate predictive markers of response to BAY63-2521 in patients suffering from Raynaud’s phenomenon.;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Measure

Time frame

Main Objective: The primary objective of the study is to investigate the safety, tolerability and pharmacodynamics of a single oral dose of BAY 63-2521 administered in patients suffering from Raynaud’s phenomenon;Secondary Objective: The secondary objective of this study is to investigate predictive markers of response to BAY63-2521 in patients suffering from Raynaud’s phenomenon.;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Germany

Contacts

Public ContactClinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026