Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From 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.
 
ClinicalTrials.gov Identifier: NCT02191254
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)

Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: Antistax® Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2004
Actual Primary Completion Date : October 2004

Arm Intervention/treatment
Experimental: Antistax®
1 tablet per day for 12 weeks
Drug: Antistax®
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline in limb volume determination [ Time Frame: Baseline, day 84 ]
    water displacement method


Secondary Outcome Measures :
  1. Changes in limb volume determination [ Time Frame: Baseline, day 21 and day 42 ]
    water displacement method

  2. Changes in the calf circumference [ Time Frame: Baseline, at day 21, 42 and 84 ]
    in centimeters

  3. Changes in the ankle circumference [ Time Frame: Baseline, at day 21, 42, and 84 ]
    in centimeters

  4. Changes in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS) [ Time Frame: Baseline, at day 21, 42, and 84 ]
  5. Global assessment of efficacy by the patient on a 4-point verbal rating scale (VRS) [ Time Frame: day 84 ]
  6. Global assessment of efficacy by the investigator on a 4-point VRS [ Time Frame: day 84 ]
  7. Global assessment of tolerability by the patient on a 4-point VRS [ Time Frame: day 84 ]
  8. Global assessment of tolerability by the investigator on a 4-point VRS [ Time Frame: Day 84 ]
  9. Number of patients with adverse events [ Time Frame: up to 12 weeks ]
  10. Number of patients with clinically significant changes in laboratory values [ Time Frame: Baseline, week 12 ]
  11. Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR)) [ Time Frame: Baseline, up to 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • 18 years of age or older
  • CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease, e.g. pigmentation), according to the CEAP classification
  • Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant diseases:

  • Decompensated cardiac insufficiency
  • Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency, renal insufficiency, lymphoedema, 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 > 3x upper limit of normal)
  • Other diseases: hyper- or hypocalcaemia, malignancies
  • Anamnestic indications of diabetic microangiopathy or polyneuropathy
  • Drug and/or alcohol abuse
  • Severe climacteric complaints: changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months
  • Immobility
  • Avalvulia
  • Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
  • State after pulmonary embolism
  • Recognised hypersensitivity to the trial drug ingredients
  • Current florid venous ulcus
  • Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compression treatment, phlebectomy, etc.

Previous treatments:

  • Patients who are on compression therapy and/or are wearing support stockings and who optimally benefit from these measures
  • Treatment with venous drugs within the last 2 weeks prior to the intake of study medication
  • Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to the intake of study medication

Concomitant treatment/non-drug therapy exclusion criteria:

  • Other venous drugs apart from the trial medication
  • Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry
  • Extensive use of laxatives
  • Major surgery requiring full anaesthesia

Other exclusion criteria:

  • Previously studied under this protocol
  • Participation in another clinical trial within the previous 90 days or during the present study
  • Patient is investigator, co-investigator, or study nurse in this study
  • 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 judgement

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191254     History of Changes
Other Study ID Numbers: 1138.4
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases