NCT00292435CompletedPhase 3
A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax Film-coated Tablets, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 202
- Locations
- 20
- Primary Endpoint
- Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
Study Overview
Brief Summary
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
Time Frame: 84 days
Secondary Outcomes
- Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84(84 days)
- Change from baseline in calf circumference on days 21, 42, and 84(21, 42 and 84 days)
- Global assessment of efficacy by the patient on day 84(84 days)
- Global assessment of efficacy by the investigator on day 84(84 days)
- Incidence of adverse events(84 days)
- Global assessment of tolerability by the patient and by the investigator on day 84.(day 84)
- Change from baseline in limb volume on days 21 and 42 determined by water displacement.(21 and 42 days)
- Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84(21, 42 and 84 days)
- Measurement of vital signs (pulse rate, blood pressure)(84 days)
Investigators
Study Sites (20)
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