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COMPLETED
NCT05299554
PHASE3

Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia

Sponsor: Immedica Pharma AB

View on ClinicalTrials.gov

Summary

This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).

Official title: A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2022-04-01

Completion Date

2026-01-15

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Chronocort

Hydrocortisone modified-release capsule 5 mg and 10 mg

Locations (21)

Neurocrine Investigational Site in California

Los Angeles, California, United States

Neurocrine Investigational Site in California

Orange, California, United States

Neurocrine Investigational Site in Florida

Jacksonville, Florida, United States

Neurocrine Investigational Site in Iowa

Iowa City, Iowa, United States

National Institutes of Health Center

Bethesda, Maryland, United States

Neurocrine Investigational Site in Michigan

Ann Arbor, Michigan, United States

Neurocrine Investigational Site in Minnesota

Rochester, Minnesota, United States

Neurocrine Investigational Site in Nevada

Las Vegas, Nevada, United States

Neurocrine Investigational Site in Texas

Dallas, Texas, United States

Neurocrine Investigational Site in Washington

Seattle, Washington, United States

Neurocrine Investigational Site in Wisconsin

Milwaukee, Wisconsin, United States

Neurocrine Investigational Site in Caen

Caen, France

Neurocrine investigational Site in Lyon

Lyon, France

Neurocrine Investigational Site in Paris

Paris, France

Neurocrine Investigational Site in Pessac

Pessac, France

Neurocrine Investigational Site in Toulouse (Children's hospital)

Toulouse, France

Neurocrine Investigational Site in Toulouse

Toulouse, France

Neurocrine Investigational Site in Asahi-ku

Yokohama, Kanagawa, Japan

Neurocrine Investigational Site in Yushima

Bunkyō-Ku, Tokyo, Japan

Neurocrine Investigational Site in Okura

Setagaya-Ku, Tokyo, Japan

Neurocrine Investigational Site in Toyama

Shinjuku-Ku, Tokyo, Japan