Efficacy and Safety CVI, Study 2, (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00292435
First received: February 15, 2006
Last updated: May 18, 2012
Last verified: May 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 15, 2006 | ||||
| Last Updated Date | May 18, 2012 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE |
Change from baseline in limb volume determination at day 84 (water displacement method) | ||||
| Change History | Complete list of historical versions of study NCT00292435 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Change from baseline in limb volume determination at day 21 and day 42 (water displacement method) o Change from baseline in the calf circumference at day 21, 42, and 84 o Change from baseline in the subjective symptoms | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety CVI, Study 2, (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI) | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | To determine efficacy and safety of Antistax 360 mg tablets in chronic venous insufficiency linked o edema (swelling) and subjective symptoms |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
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| Condition ICMJE | Venous Insufficiency | ||||
| Intervention ICMJE | Drug: Read vine leaf extract (AS 195) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | April 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Not Provided | ||||
| Gender | Not Provided | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, Czech Republic, Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00292435 | ||||
| Other Study ID Numbers ICMJE | 1138.10 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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