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NCT00621894 · ClinicalTrials.gov registry record · Phase 2

Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT00621894 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 23 participants.

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The verdict

NCT00621894, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in healthy volunteers. This study will examine the safety, tolerability and efficacy of 7.5 mg capsules of LGD-4665 to increase platelets compared to placebo, randomized 2:1, during blinded treatment for 6 weeks. Evaluation of platelet counts, bleeding scores and safety parameters will be done weekly. All patients are eligible to continue on active, open LGD-4665 treatment for an additional 12 weeks with optimal adjustment of dose for each patient.

Interventions

  • DRUG Placebo
  • DRUG LGD-4665

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2008-03-15
Est. Completion 2009-05-15
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00621894

The ClinicalTrials.gov registry entry for NCT00621894 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00621894 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00621894 about?

NCT00621894 is a clinical study titled "Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation". The purpose of this study is to assess the ability of LGD-4665 given daily by mouth to increase platelet counts in the treatment of patients with ITP (immune thrombocytopenic purpura). LGD-4665 increased platelet counts safely and tolerably compared to placebo in healthy volunteers. This study will ...

What is the current status of trial NCT00621894?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2008-03-15. Estimated completion is 2009-05-15.

What interventions are being tested in trial NCT00621894?

The interventions under investigation include: Placebo (DRUG), LGD-4665 (DRUG).

Who is sponsoring clinical trial NCT00621894?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

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

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.