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ataciguat · 3 trials · 3 indications
The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern.
The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Transitioning from sitting to standing is a functional test that will allow us to examine the effects of Ataciguat on blood pressure regulation in response to a relevant orthostatic stress.
The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Tilt table testing will allow us to examine the effects of Ataciguat on blood pressure regulation in response to a tightly controlled orthostatic stress.
The primary objective of the current study is to determine whether Ataciguat (HMR1766) is well-tolerated by patients with moderate calcific aortic valve stenosis. In this particular patient population, incidence of orthostatic intolerance/symptomatic hypotension is a potential concern. Evaluating subject perceptions of light-headedness/orthostatic intolerance will help us to understand the relationship between changes in blood pressure and changes in symptoms in this patient population before and after treatment with Ataciguat.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | First period: Ataciguat - Second period: Placebo |
| 2 | EXPERIMENTAL | First period: Placebo - Second period: Ataciguat |
| 3 | EXPERIMENTAL | dose level 2 |
| 4 | EXPERIMENTAL | dose level 3 |
| 5 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Placebo gel capsule, dosage matches number of Ataciguat capsules for each respective dose, capsules taken once daily with breakfast for 14 consecutive days. |
| Ataciguat | ACTIVE_COMPARATOR | Ataciguat, orally administered gel capsule, 50, 100, or 200 mg, once per day with breakfast for 14 consecutive days |
| Name | Type | Description |
|---|---|---|
| ataciguat (HMR1766) | DRUG | oral administration 200mg once daily for 28 days |
| placebo | DRUG | oral administration once daily for 28 days |
| cilostazol | DRUG | oral administration |
| Ataciguat | DRUG | - |
Inclusion Criteria: * Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months. Exclusion Criteria: * Presence or history of cancer within the past five years * Patients with a history of HIV infecti...
Ataciguat is an investigational small molecule being studied for cardiovascular and pain conditions, including aortic valve stenosis, intermittent claudication, and neuropathic pain. It is developed by Sanofi and is currently in clinical development, with trials completed for these indications.
Ataciguat is a soluble guanylate cyclase activator that works by stimulating the enzyme to produce cyclic GMP, which promotes vasodilation and may help in conditions like intermittent claudication and aortic valve stenosis. Its mechanism is relevant to its cardiovascular applications.
Ataciguat is developed by Sanofi, a global pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has conducted clinical trials for Ataciguat across multiple indications, including aortic valve stenosis, intermittent claudication, and pain.
Ataciguat has completed Phase 1 and Phase 2 clinical trials. The most advanced completed trial was a Phase 2 study for intermittent claudication, while a Phase 1 trial for aortic valve stenosis has also been completed. Ataciguat is not approved and remains investigational.
Ataciguat has been studied in three completed clinical trials. NCT00443287 was a Phase 2 trial for intermittent claudication with 553 participants. NCT00799656 was a Phase 2 trial for neuropathic pain with 62 participants. NCT02049203 was a Phase 1 trial for aortic valve stenosis with 44 participants.
Ataciguat is also known as HMR1766. In clinical trials, it has been referred to by both names, with the Phase 2 intermittent claudication study titled as an efficacy and safety study of HMR1766. Both names refer to the same investigational drug.