Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GTX-104 · 2 trials · 2 indications
Hypotension events requiring medical treatment
Maximum concentration
Area under the concentration-time curve
| Arm | Type | Description |
|---|---|---|
| GTX-104 | EXPERIMENTAL | GTX-104 is a sterile concentrate of 10 mg nimodipine/5 mL (2 mg/mL), to be diluted in normal saline to obtain a dosing solution composed of dispersed micelles containing nimodipine for IV infusion. It will be administered as a continuous IV infusion of 0.15 mg/hour and a 30-minute IV bolus of 4 mg every 4 hours for up to 21 days |
| Oral nimodipine | ACTIVE_COMPARATOR | Oral nimodipine is a soft gelatin capsule. The dose is 60 mg (two 30 mg capsules) every 4 hours for up to 21 consecutive days. |
| Treatment A (GTX-104 IV, Test): | EXPERIMENTAL | Nimodipine was administered by infusion over 72 hours. |
| Treatment B (NIMOTOP, RLD): | EXPERIMENTAL | Nimodipine capsules (RS) administered orally with 240 mL of water at a dose level of 60 mg (two 30 mg capsules) q4h for 72 hours. |
| Name | Type | Description |
|---|---|---|
| GTX-104 | DRUG | Nimodipine IV infusion |
| Nimotop 30 MG Oral Capsule | DRUG | Oral nimodipine capsules |
| Nimodipine Capsules | DRUG | Nimodipine capsules (reference formulation) |
Inclusion Criteria: 1. Male or female ≥18 years of age. 2. Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) based on CT scan and angiography (computed tomography angiography \[CTA\], magnetic resonance angiography \[MRA\], or digital subtraction angiography \[DSA\]). 3. Hunt and Hess score fr...