Active, Not Recruiting

Study Overview

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF.

The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

View full trial information on Clinicaltrials.gov
NATIONAL TRIAL REFERENCE NUMBER NCT04945460
Merck Protocol ID MK-7962-007
Conditions Hypertension, Pulmonary
Age Range 18 - 85
Sex All
Trial Phase 1
Trial start and end dates [12-29-2021] [09-12-2025]

Study Details

Patient Participation

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions

Hypertension, Pulmonary

View full trial eligibility

Trial Phase 2

In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial Locations (57)

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Frequently Asked Questions

About the Study

Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study s purpose, assessments, procedures, potential benefits
and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.

Privacy, Stopping Participation, Costs, and Permission

The study team respects and protects your privacy and will not share your information except as required by law and will store your personal
information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more
information about how your privacy will be maintained.

Yes, your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw
early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final
visit and return any unused study drugs.

No, you will receive the study drugs at no cost. You will also get all study related medical tests at no cost.

No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may
contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.

About Research Studies

A research study, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run
studies to test whether an investigational study drug is safe and effective. These research studies may help doctors find new ways to help prevent,
detect, or treat health problems.

Participant safety is the priority. There are rules in place to help protect the rights, safety, and well being of people who volunteer for research
studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the research study. In the US, this group is called an IRB or
Institutional Review Board. An IRB is made up of doctors, scientists, and other members of the community.

Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical
history and current medical status against the eligibility criteria. They will determine whether you are eligible to participate. You may also be asked
to provide information from your medical records to help the study team determine whether you may be eligible.

An investigational study drug is a drug that hasn t yet been approved for use in the general public. In order to be approved, the investigational
study drug must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.

If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.

For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/

What can you do next?

Submit your information

Interested in this research study? Submit your information to be contacted to see if you may qualify.

The information you provide will be kept confidential.

Get Started

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

Contact our Trial Information Center

To learn more, call 1-888-577-8839.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

Contact our Trial Information Center

To learn more, call 1-888-577-8839.

NATIONAL TRIAL REFERENCE NUMBER

NCT04945460

When you talk with your doctor or clinical team member, please have the national trial reference number available.

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