Trial Profile
A pahse 2 clinical study of levosimendan to treat patients with Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)
Planning
Phase of Trial:
Phase II
Latest Information Update: 04 Apr 2018
At a glance
- Drugs Levosimendan (Primary)
- Indications Pulmonary hypertension
- Focus Proof of concept; Therapeutic Use
- Sponsors Tenax Therapeutics
- 04 Apr 2018 According to a Tenax Therapeutics media release, the company will finalize trial protocol for IND submission and continue preparations to start of the trial by late June or July.
- 04 Apr 2018 According to a Tenax Therapeutics media release, the FDA agreed that the new Phase 2 clinical protocol can be submitted under the existing IND, and supported the study design and endpoints for demonstrating proof-of-concept in PH-HFpEF patients.
- 01 Mar 2018 According to a Tenax Therapeutics media release, the company anticipates to begin this trial in the later part of Q2 0218.