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NCT00082628 · ClinicalTrials.gov registry record · Phase 3

Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

A Phase 3 study, sponsored by EMD Serono.

Completed
Registry status
Phase 3
Development phase
326
Enrollment target

NCT00082628 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 326 participants.

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The verdict

NCT00082628, a Phase 3 study, has completed, sponsored by EMD Serono.

COMPLETED
Registry status
Phase 3
Development phase
326 participants
Enrollment target

Study Summary

The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.

Interventions

  • DRUG Placebo
  • DRUG Serostim® 4 mg
  • DRUG Serostim® 2 mg

Trial Details

FieldValue
Enrollment Target 326 participants
Start Date 2004-05-28
Est. Completion 2005-09-28
Phase Phase 3

Sponsor

EMD Serono

71 total trials

What the Registry Record Tells You About NCT00082628

The ClinicalTrials.gov registry entry for NCT00082628 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00082628 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00082628 about?

NCT00082628 is a clinical study titled "Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients". The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more e...

What is the current status of trial NCT00082628?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2004-05-28. Estimated completion is 2005-09-28.

What interventions are being tested in trial NCT00082628?

The interventions under investigation include: Placebo (DRUG), Serostim® 4 mg (DRUG), Serostim® 2 mg (DRUG).

Who is sponsoring clinical trial NCT00082628?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.