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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001635-21 | EudraCT Number |
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This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIA-2291 | Experimental |
| |
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIA-2291 | Drug | 100 mg, oral dosing, 1 time daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Cross-sectional Area of Macrophages in Plaque Tissue | Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue | Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue | 12 weeks |
| Change From Baseline in Whole Blood Leukotriene B4 Production |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Taub, MD | VIA Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedali Riuniti Ancona | Ancona | Italy | ||||
| Presidio Ospedaliero SS Filippo e Nicola |
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Patients recruited from three Italian Medical Centers
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| ID | Title | Description |
|---|---|---|
| FG000 | VIA-2291 | 100-mg dose |
| FG001 | Matching Placebo | Placebo Dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VIA-2291 | 100-mg dose |
| BG001 | Matching Placebo | Placebo Dose |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Cross-sectional Area of Macrophages in Plaque Tissue | Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody | Evaluable Population with histological sections available | Posted | Mean | 95% Confidence Interval | Percent Area | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VIA-2291 | 100-mg dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
The small number, less than optimal quality, and diversity of types of plaque samples posed a significant limitation to the interpretation of the plaque data in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Cunningham, MD | Tallikut Pharmaceuticals, Inc. | 312-505-0420 | brian@baycitycapital.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C096921 | atreleuton |
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| Placebo | Drug | oral dosing, 1 time daily for 12 weeks |
|
| Baseline and 12 weeks |
| Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine | Baseline and 12 Weeks |
| Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Baseline and 12 weeks |
| Avezzano |
| Italy |
| Centro Studi Sull'Invecchiamento | Chieti Scalo | Italy |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Schedule Change |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue | Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue | Evaluable Population with histological sections available | Posted | Mean | 95% Confidence Interval | Percent Area | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Whole Blood Leukotriene B4 Production | Evaluable Population | Posted | Least Squares Mean | 95% Confidence Interval | pg/ml | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine | Evaluable Population | Posted | Geometric Mean | 95% Confidence Interval | Percent Change | Baseline and 12 Weeks |
|
|
|
|
| Secondary | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Evaluable population with both baseline and visit 8 results | Posted | Least Squares Mean | 95% Confidence Interval | mg/L | Baseline and 12 weeks |
|
|
|
|
| 4 |
| 24 |
| 18 |
| 24 |
| EG001 | Matching Placebo | Placebo Dose | 1 | 26 | 9 | 26 |
| BENIGN RENAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD UREA INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD AMYLASE INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD BILIRUBIN UNCONJUGATED INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| BLOOD UREA INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA (9.0) | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| GLYCOSURIA | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| GOUT | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| LIPASE INCREASED | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| MESENTERIC ARTERY STENOSIS | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| NEURALGIA | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| POSTOPERATIVE FEVER | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
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