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Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)

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ClinicalTrials.gov Identifier: NCT02184234
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

Main objective: Safety and tolerability of Antistax® film coated tablets

Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency


Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: Antistax film coated tablets Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-week, Open, Multicentre Safety Trial to Evaluate the Tolerability Profile of Antistax® Film Coated Tablets (Extr. Vitis Viniferae Siccum), 360 mg/Day Per os, in Male and Female Patients Suffering From Chronic Venous Insufficiency
Study Start Date : June 2001
Actual Primary Completion Date : October 2001

Arm Intervention/treatment
Experimental: Antistax film coated tablets Drug: Antistax film coated tablets



Primary Outcome Measures :
  1. Number and intensity of serious and non-serious Adverse Events [ Time Frame: up to 6 weeks ]

Secondary Outcome Measures :
  1. Global tolerability assessment by the patient and investigator [ Time Frame: after 42 days of treatment ]
  2. Vital sign parameters (blood pressure and pulse rate) [ Time Frame: at screening and after 6 weeks ]
  3. Subjective symptoms rated on a 10-cm Visual Analog Scale (VAS) [ Time Frame: Baseline and after 6 weeks ]
  4. Global assessment of efficacy by the patient and investigator [ Time Frame: after 6 weeks ]


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema
  • Male or female out-patients of any ethnic origin
  • Age ranging from 25 to 75 years

Exclusion Criteria:

  • Known hypersensitivity to any ingredients of the study medication
  • Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances
  • Florid venous ulcers
  • Arterial occlusive disease, irrespective of the severity
  • Phlebitis or thrombophlebitis
  • Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc.
  • Evidence of diabetic micro-angiopathy or polyneuropathy in medical history
  • Poor general health (based on the investigator's judgement)
  • Addiction to alcohol abuse
  • Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial
  • Women of child-bearing age not using any reliable contraceptive methods
  • Pregnant or lactating women
  • Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days
  • Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02184234     History of Changes
Other Study ID Numbers: 1138.5
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases