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Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication
Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Experimental | Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test. |
|
| Placebo | Placebo Comparator | Single placebo intake approximately 2 hours before the treadmill test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil 100mg single oral dose | Drug | Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking duration on treadmill | Treadmill test with consttant load procedure 3.2 km/h H 10% slope up to 15 minutes followed by incremental load according tpo the Bruce protocole thereafter. | 2 hours after treatment intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loukman OMARJEE, MD | University Hospital, Angers | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31152977 | Derived | Omarjee L, Le Pabic E, Custaud MA, Fontaine C, Locher C, Renault A, Jaquinandi V, Azzola V, Barbeau-Terrier C, Laporte I, Ripoche M, Onillon Y, Chretien JM, Daniel V, Chao de la Barca JM, Homedan C, Reynier P, Abraham P, Mahe G. Effects of sildenafil on maximum walking time in patients with arterial claudication: The ARTERIOFIL study. Vascul Pharmacol. 2019 Jul-Aug;118-119:106563. doi: 10.1016/j.vph.2019.05.003. Epub 2019 May 30. |
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| Placebo, Oral intake single dose | Drug | Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope) |
|
|
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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