RECRUITING

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-interventional study to assess the prevalence of endogenous hypercortisolism (eHC) in patients with resistant hypertension (rHTN) and will enroll approximately 1000 patients at approximately 45 sites in the United States (US). Each patient will have an initial visit for screening. After eligibility is confirmed, a limited exam will be performed and demographic and medical history will be collected. Non-fasting labs and a urine collection will also be done. A second visit will be a fasting blood draw at 8 AM after taking 1 mg of dexamethasone the night before at 11 PM. Cortisol level and study labs will also be collected. After the lab results are obtained, a third visit will be scheduled only for patients with eHC and will include a non-fasting blood draw at 8 AM and scheduling of a non-contrast CT scan.

Official Title

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension in the United States of America (MOMENTUM)

Quick Facts

Study Start:2025-03-28

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06829537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Each patient must meet all of the following criteria to be enrolled in the study: * Signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF) prior to any study-specific screening procedures. * Male/female patients must be 18 years or older at the time of signing the informed consent. * Meet either of the following criteria: * Has rHTN, defined by the American Heart Association as BP above target (systolic ≥ 130 mmHg for purposes of this study) despite concurrent use of 3 or more antihypertensive medications from different classes at their maximally tolerated doses, and 1 of these agents is a diuretic. * Or, has rHTN, defined by the American Heart Association as SBP at target or above target requiring concurrent use of 4 or more antihypertensive medications of different classes.	* Patients who meet any of the following criteria will not be permitted entry to the study: * White coat hypertension, ie, elevated BP in the office only, as determined by the Investigator. * Non-adherence to BP medications, as determined by the Investigator. * Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening. For temporary exposures to oral glucocorticoids the Medical Monitor may be consulted to determine eligibility. * Has an historical estimated glomerular filtration rate (eGFR) \< 30. * Has severe untreated sleep apnea as determined by the Investigator. * Has excessive alcohol consumption (eg, \> 14 units/week for male, \> 7 units/week for female) as determined by the Investigator. * Has severe acute psychiatric, medical, or surgical illness, as determined by the Investigator. * Is a woman who is pregnant or lactating. For women of childbearing potential, a urine pregnancy test must be negative before doing the DST. A woman of childbearing potential includes women \< 50 years old, women whose surgical sterilization was performed \< 6 months ago, and women who have had a menstrual period in the last 12 months. * Is a woman who is on oral contraceptive pills (OCPs). Women on OCPs may be screened but must be willing and able to stop OCPs for at least 6 weeks prior to screening assessments. OCPs can be resumed immediately after the blood draw for the DST. * Has history of congenital adrenal hyperplasia. * Has had the diagnosis of Cushing syndrome and/or has used or plans to use any of the following treatments for Cushing syndrome: * Is unable to take dexamethasone due to a history of hypersensitivity or severe reaction to dexamethasone. * Is a staff member working directly on the study or is a family member of someone working directly on the study, including any of the Sponsor's employees, the Investigator or the site staff.

Inclusion Criteria

Exclusion Criteria

* Each patient must meet all of the following criteria to be enrolled in the study:
* Signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF) prior to any study-specific screening procedures.
* Male/female patients must be 18 years or older at the time of signing the informed consent.
* Meet either of the following criteria:
* Has rHTN, defined by the American Heart Association as BP above target (systolic ≥ 130 mmHg for purposes of this study) despite concurrent use of 3 or more antihypertensive medications from different classes at their maximally tolerated doses, and 1 of these agents is a diuretic.
* Or, has rHTN, defined by the American Heart Association as SBP at target or above target requiring concurrent use of 4 or more antihypertensive medications of different classes.

* Patients who meet any of the following criteria will not be permitted entry to the study:
* White coat hypertension, ie, elevated BP in the office only, as determined by the Investigator.
* Non-adherence to BP medications, as determined by the Investigator.
* Systemic glucocorticoid medications exposure (excluding inhalers or topical) within 3 months of screening. For temporary exposures to oral glucocorticoids the Medical Monitor may be consulted to determine eligibility.
* Has an historical estimated glomerular filtration rate (eGFR) \< 30.
* Has severe untreated sleep apnea as determined by the Investigator.
* Has excessive alcohol consumption (eg, \> 14 units/week for male, \> 7 units/week for female) as determined by the Investigator.
* Has severe acute psychiatric, medical, or surgical illness, as determined by the Investigator.
* Is a woman who is pregnant or lactating. For women of childbearing potential, a urine pregnancy test must be negative before doing the DST. A woman of childbearing potential includes women \< 50 years old, women whose surgical sterilization was performed \< 6 months ago, and women who have had a menstrual period in the last 12 months.
* Is a woman who is on oral contraceptive pills (OCPs). Women on OCPs may be screened but must be willing and able to stop OCPs for at least 6 weeks prior to screening assessments. OCPs can be resumed immediately after the blood draw for the DST.
* Has history of congenital adrenal hyperplasia.
* Has had the diagnosis of Cushing syndrome and/or has used or plans to use any of the following treatments for Cushing syndrome:
* Is unable to take dexamethasone due to a history of hypersensitivity or severe reaction to dexamethasone.
* Is a staff member working directly on the study or is a family member of someone working directly on the study, including any of the Sponsor's employees, the Investigator or the site staff.

Contacts and Locations

Study Contact

Clinical Trial Lead

CONTACT

650.684.9192

corceptstudy311@corcept.com

Daniel Einhorn, MD

CONTACT

Study Locations (Sites)

Site 378

Huntington Park, California, 90255

United States

Site 535

Northridge, California, 91324

United States

Site 379

Redondo Beach, California, 90247

United States

Site 542

Santa Maria, California, 93454

United States

Site 387

Tarzana, California, 91356

United States

Site 444

Edgewater, Florida, 32132

United States

Site 525

Miami, Florida, 33155

United States

Site 527

Miami, Florida, 33173

United States

Site 537

Port Charlotte, Florida, 33952

United States

Site 061

Metairie, Louisiana, 70006

United States

Site 440

Rockville, Maryland, 20854

United States

Site 067

Boston, Massachusetts, 02115

United States

Site 530

Troy, Michigan, 48085

United States

Site 371

Las Vegas, Nevada, 89148

United States

Site 070

Albany, New York, 12203

United States

Site 536

Durham, North Carolina, 27701

United States

Site 059

Wilmington, North Carolina, 28401

United States

Site 436

Cincinnati, Ohio, 45219

United States

Site 456

Austin, Texas, 78759

United States

Site 370

Dallas, Texas, 75230

United States

Site 526

Houston, Texas, 77054

United States

Site 408

Lufkin, Texas, 75904

United States

Site 369

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Corcept Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-28

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-03-28

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Hypercortisolism
Resistant Hypertension

Additional Relevant MeSH Terms

Resistant Hypertension
Hypercortisolism