Clinical trial of MK-5475 in adults with high blood pressure in the lungs and COPD

• Research type

  Research Study

• Full title

  A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

• IRAS ID

  1006730

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Pulmonary hypertension (PH) is a strong predictor of mortality in COPD patients, with a 5-year survival rate of 36% reported for COPD. PH due to COPD is a type of high blood pressure in the arteries that go from the heart to the lungs. It causes extra work for the heart and makes it hard to breathe and be physically active. When people with PH due to COPD take certain blood pressure medicines by mouth such as pills, it may cause low blood pressure and low oxygen levels in the body. MK5475 is a study medication breathed into the lung using an inhaler. Researchers think that using an inhaler to take this study medication will lower the blood pressure in the arteries of the lungs only, without causing low blood pressure and low oxygen levels in the rest of the body.
  This trial is testing MK-5475 in adults with PH-COPD. MK-5475 is experimental. It has not been approved for treatment of PH-COPD. The trial will compare MK-5475 to matching placebo. A placebo has no active ingredients. The goal of this study is to learn if the PH symptoms change in people who take MK-5475 using an inhaler, based on how far they can walk in a 6-minute walking test.
  There will be a screening phase, lasting about 42 days, to see if patients can join the trial.
  Approximately 120 eligible participants between 4 and 80 years old with PH due to COPD will take part in the study. Participants will then be assigned by chance to take MK5475 or a placebo for 6 months. Participants will have a 3 in 1 chance of taking the placebo. MK-5475 or placebo will be taken as oral inhalation once daily for 24 weeks in the Base period (18 months for extension period). Participants will be in the trial for approximately 43 months and will visit the site about 30 times. A telephone follow-up visit will occur 2 weeks after the last study visit for AE monitoring. The trial will take place at 2 trial centres in UK.
  The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  Wales REC 1

• REC reference

  22/WA/0343

• Date of REC Opinion

  15 Jun 2023

• REC opinion

  Further Information Favourable Opinion