Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator

Single Dose, Double-blind, Placebo-controlled, Single Center, Randomized Cross-over Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Properties of BAY63-2521 After Oral Dosing in 20 Patients With Raynaud's Phenomenon (RP)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926847

Acronym

DIGIT

Enrollment

Registered

2013-08-21

Start date

2013-10-31

Completion date

2014-06-30

Last updated

2014-06-16

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

Conditions

Raynaud Disease

Keywords

Digital ischemia, Raynaud's phenomenon

Brief summary

Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.

Interventions

DRUGRiociguat (Adempas, BAY63-2521)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients suffering from Raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin: * idiopathic (primary) * limited cutaneous Scleroderma associated * diffuse cutaneous Scleroderma associated * mixed connective tissue disease associated

Exclusion criteria

* Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates * Smokers * Systolic blood pressure (SBP) below 105mmHg at rest

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events as a measure of safety and tolerability	5 weeks
Blood pressure	5 weeks
Pulse rate	5 weeks
Incidence of participants showing changes during clinical laboratory and hematology assessment	From baseline to 5 weeks
Plasma concentration at 2 h after riociguat administration	After 2 hours
Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging	At baseline and after 2h
Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging	At baseline and after 2h

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026