Johnson & Johnson to halt hypertension drug Macitentan study
The study was deemed "futile" and failed to improve exercise capacity in a broad population including inoperable patients compared to a placebo, J&J said.
Raritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced its decision to stop the Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) due to futility. The decision to stop the trial was made in accordance with a recommendation by the study’s independent data monitoring committee following a pre-planned interim analysis. No new safety signals were observed.
The interim results of MACiTEPH do not impact any of the Company's commercialized pulmonary hypertension medicines. Additionally, the pivotal Phase 3 UNISUS study, which aims to establish the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose in patients with pulmonary arterial hypertension, is currently continuing as planned.
MACiTEPH is a prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study in patients with CTEPH. It evaluates the efficacy and safety of macitentan 75 mg compared to placebo on exercise capacity, the primary efficacy endpoint, in a broad population including inoperable patients and those who underwent mechanical treatment, including pulmonary endarterectomy or balloon pulmonary angioplasty.
Read also: Conduct Phase-III clinical trial in India: CDSCO panel tells Johnson and Johnson Over Guselkumab
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.