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NCT03743051 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
NCT03743051 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 318 participants.
The verdict
NCT03743051, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
Study Summary
The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo. Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.
Interventions
- DRUG Placebo Oral Tablet
- DRUG Anamorelin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2023-02-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03743051
The ClinicalTrials.gov registry entry for NCT03743051 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 318 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03743051 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03743051 about?
NCT03743051 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)". The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as fol...
What is the current status of trial NCT03743051?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2019-03-05. Estimated completion is 2023-02-11.
What interventions are being tested in trial NCT03743051?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Anamorelin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03743051?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
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