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Antistax® in Patients With Chronic Venous Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02191280
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II

Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: Antistax®, low dose Drug: Antistax®, high dose Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
Study Start Date : April 1998
Actual Primary Completion Date : September 1998

Arm Intervention/treatment
Experimental: Antistax®, low dose Drug: Antistax®, low dose
Experimental: Antistax®, high dose Drug: Antistax®, high dose
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Changes from baseline of limb volume [ Time Frame: Baseline, day 84 ]
    determined by water displacement

Secondary Outcome Measures :
  1. Changes of limb volume [ Time Frame: Baseline, days 42 and 98 ]
    determined by water displacement

  2. Measurement of calf circumference [ Time Frame: Baseline, days 42, 84 and 98 ]
    in centimeters

  3. Measurement of ankle circumference [ Time Frame: Baseline, days 42, 84 and 98 ]
    in centimeters

  4. Assessment of subjective symptoms on a visual analogue scale (VAS) [ Time Frame: Baseline, days 42, 84 and 98 ]
  5. Assessment of global efficacy by patient on a 4-point verbal rating scale [ Time Frame: days 42, 84 and 98 ]
  6. Assessment of global efficacy by investigator on a 4-point verbal rating scale [ Time Frame: days 42, 84 and 98 ]
  7. Assessment of global tolerability by patient on a 4-point verbal rating scale [ Time Frame: days 42, 84 and 98 ]
  8. Assessment of global tolerability by investigator on a 4-point verbal rating scale [ Time Frame: days 42, 84 and 98 ]
  9. Number of patients with adverse events [ Time Frame: up to 14 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

Inclusion Criteria:

  • Male or female
  • Between 25 and 75 years of age
  • CVI I or CVI II (without expanded trophic disturbances)
  • Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

  • Decompensated cardiac insufficiency
  • Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)
  • Peripheral arterial disease (ankle/arm pressure index < 0.9)
  • Current acute phlebitis or thrombosis
  • Renal insufficiency (Serum creatinine > 1.5 mg/dl)
  • Liver disease (SGPT (ALAT) > 3x upper limit of normal)
  • Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
  • Anamnestic indications of diabetic microangiopathy or polyneuropathy
  • Drug and/or alcohol abuse
  • Severe climacteric complaints
  • Immobility
  • Avalvulia
  • Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
  • State after pulmonary embolism
  • Recognized hypersensitivity to the trial drug ingredients
  • Current florid venous ulcus
  • Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

  • Treatment with venous drugs within the last 4 weeks
  • Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days
  • Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days
  • Changes in post-menopausal Hormone replacement within the last 2 months

Concomitant treatment/non-drug therapy exclusion criteria:

  • Other venous drugs apart from the trial medication
  • Compression therapy
  • Venous surgery at the leg(s)
  • Extensive use (on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
  • Major surgery requiring full anesthesia

Other exclusion criteria:

  • Previously studied under this protocol
  • Participation in another clinical trial within the previous 90 days or during the present study
  • Patients who have visited a sauna or had other thermal applications in the previous day before any visit
  • Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
  • Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
  • Patients in a bad general health state according to the investigator's judgment

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Responsible Party: Boehringer Ingelheim Identifier: NCT02191280     History of Changes
Other Study ID Numbers: 1138.2
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs