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INDAPAMIDE HEMIHYDRATE

Clinical trials are studying INDAPAMIDE HEMIHYDRATE in people with chronic post-surgical hypoparathyroidism. These studies are looking mainly at whether treatment can change urinary calcium levels and how well it works compared with placebo. The trial data here include adults in a Phase 3 interventional study.

Table of Contents

Trial overview

The available trial data describe one interventional study of INDAPAMIDE HEMIHYDRATE called HYPOCARE TREAT.[1] It is studying people with chronic post-surgical hypoparathyroidism.[1]

This study is in Phase 3, which means it is a later-stage clinical trial that looks at how well the treatment works in people with the condition.[1]

Who is being studied

The target population is patients with chronic post-surgical hypoparathyroidism.[1] “Post-surgical” means the condition happened after surgery, and “chronic” means it is long-lasting.[1]

The source data do not list more details about age, sex, or other entry rules.[1]

Study design and treatment groups

HYPOCARE TREAT is an interventional trial, so researchers are giving a study treatment and comparing results.[1] The study compares daily INDAPAMIDE HEMIHYDRATE with placebo tablets.[1]

The brief summary says patients receive daily treatment for 14 days, and the comparison is made against placebo.[1]

What the trial measures

The main outcome is 24-hour urinary calcium excretion, which means the amount of calcium passed in urine over one full day.[1] Researchers are checking how this changes after 7 days and after 14 days of treatment.[1]

This endpoint helps show whether the study treatment changes calcium loss in urine in people with chronic post-surgical hypoparathyroidism.[1]

Trial status and size

The study status is Authorised, which means it has been approved to run.[1] The planned enrollment is 24 participants, so this is a small trial.[1]

Key terms explained

Placebo means a tablet that looks like the study medicine but does not contain the active treatment.[1] Researchers use it to compare results fairly.[1]

Endpoint means the main result the researchers measure in the trial.[1] In this study, the endpoint is the change in urinary calcium over time.[1]

Enrollment is the number of people planned for the trial.[1] Here, the planned enrollment is 24 people.[1]

Trial ID Phase Condition studied Status Enrollment Main endpoint
2024-516000-41-01 Phase 3 Chronic post-surgical hypoparathyroidism Authorised 24 Changes in 24-hour urinary calcium excretion after 7 and 14 days

FAQ

  • What is being studied in the INDAPAMIDE HEMIHYDRATE trial? The trial is studying whether daily INDAPAMIDE HEMIHYDRATE changes 24-hour urinary calcium excretion. It compares INDAPAMIDE HEMIHYDRATE with placebo tablets.
  • Who can take part in this trial? The trial is for patients with chronic post-surgical hypoparathyroidism. The source data do not give more details about age or other entry rules.
  • What phase is this clinical trial? This is a Phase 3 trial. Phase 3 studies usually test how well a treatment works in a larger group of people and continue to watch safety and outcomes.
  • What results are the researchers measuring? The main results are changes in 24-hour urinary calcium excretion after 7 days and after 14 days of treatment. This helps show whether the study treatment affects calcium loss in urine.
  • Is this trial treatment or observation only? It is an interventional study, which means researchers give a treatment and compare it with placebo. The study is authorised.

Ongoing Clinical Trials on INDAPAMIDE HEMIHYDRATE

  • Study on Indapamide for Patients with Chronic Post-Surgical Hypoparathyroidism

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Hypoparathyroidism: A condition where the parathyroid glands do not make enough hormone. In this trial, the condition is chronic and came after surgery.
  • Post-surgical: Happening after an operation or surgery.
  • Chronic: Long-lasting or ongoing over time.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and continues to collect safety information.
  • Interventional study: A study where researchers give a treatment or placebo and then compare results.
  • Placebo: A tablet that looks like the study medicine but has no active treatment in it.
  • 24-hour urinary calcium excretion: The amount of calcium passed in urine over one full day. Researchers measure it to see how the body is handling calcium.
  • Outcome: A result the researchers measure to see what happened during the trial.
  • Enrollment: The number of people planned for the study.
  • Authorised: Approved to run by the proper review process.

References