Efficacy and Safety of Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities: A Randomized Placebo-Controlled Double-Blind Clinical Trial (SuloPrima)

NCT05005052 Phase 3 UNKNOWN

This study compares the efficacy and safety of sulodexide (Vessel) to placebo in patients with chronic venous disease of the lower extremities. The primary hypothesis is that more patients will achieve a decrease in rVCSS score of at least 4 points with sulodexide than with placebo.

Details

Lead sponsor	Value Outcomes Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	290
Start date	2021-11-25
Completion	2023-12

Conditions

• Chronic Venous Disease
• Chronic Insufficiency Venous

Interventions

• Vessel
• Placebo

Primary outcomes

• Revised Venous Clinical Severity Score (rVCSS) — 24 weeks of treatment
  A minimal decrease in rVCSS score by 4 points will be considered a clinically significant response to treatment.

Countries

Czechia