Conditions: ACE Inhibitor Induced Angioedema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 79
Healthy volunteers: no

Brief summary:
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Detailed description:

Arms:
arm 1: Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo. arm 2: Administered as two SC 3 mL injections arm 3: Administered as two 3 mL SC injections, each containing 30 mg ecallantide arm 4: Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.

Interventions: intervention 1: ecallantide 60 mg intervention 2: ecallantide 30 mg intervention 3: ecallantide 10 mg intervention 4: placebo intervention 5: placebo match for 30 mg ecallantide arm intervention 6: placebo match for 10 mg ecallantide arm
Intervention descriptions: intervention 1: Administered as two 3 mL SC injections, each containing 30 mg ecallantide intervention 2: Administered as one 3 mL SC injection containing 30 mg ecallantide intervention 3: Administered as one 3 mL SC injection containing 10 mg ecallantide. intervention 4: Administered as two SC 3 mL injections intervention 5: One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm. intervention 6: One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.

Protocol document: