A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Corcept Therapeutics
Study ID
NCT04308590
Phase
PHASE3
Status
Completed

Conditions

  • Hypercortisolism

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Relacorilant — DRUG
    Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.
  • Placebo — OTHER
    Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.

Study Details

This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance (DM/IGT) and/or uncontrolled systolic hypertension (HTN).

Key Dates

First listed
Mar 16, 2020
Start date
Jul 27, 2020
Status verified
Aug 2025
Primary completion
Sep 19, 2024
Completion
Sep 19, 2024

Study Design

Enrollment
137 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relacorilant
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
  • Placebo Comparator: Placebo
    Patients will receive placebo matched to study drug once daily.

Primary Outcome Measure

Change in Average 24-hour SBP [ Time Frame: Baseline and Week 22 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Site 27BirminghamAlabama35294-
Site 17StanfordCalifornia94305-
Site 53TorranceCalifornia90502-
Site 07AtlantaGeorgia30318-
Site 16IndianapolisIndiana46202-
Site 09MetairieLouisiana70006-
Site 36BaltimoreMaryland21287-
Site 11Fall RiverMassachusetts02721-
Site 33RochesterMinnesota55905-
Site 06JacksonMississippi39202-
Site 54RenoNevada89511-
Site 10JamaicaNew York11432-
Site 44New YorkNew York10021-
Site 01WilmingtonNorth Carolina28401-
Site 30ClevelandOhio44195-
Site 21ColumbusOhio43201-3209-
Site 02SummervilleSouth Carolina29485-
Site 20DallasTexas75390-
Site 03El PasoTexas79935-
Site 05Fort WorthTexas76132-
Site 08HoustonTexas77079-
Site 15SpokaneWashington99202-

Find similar trials in Birmingham, AL

By research site
Site 27· Birmingham, ALSite 17· Stanford, CASite 53· Torrance, CASite 07· Atlanta, GASite 16· Indianapolis, INSite 09· Metairie, LA

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