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NCT01395914 · ClinicalTrials.gov registry record · Phase 3
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
A Phase 3 study, sponsored by Helsinn Therapeutics (U.S.).
- Completed
- Registry status
- Phase 3
- Development phase
- 513
- Enrollment target
NCT01395914: Completed Phase 3 study, sponsored by Helsinn Therapeutics (U.S.).
NCT01395914 is a Phase 3 study that has completed, run by Helsinn Therapeutics (U.S.). The registered enrollment target is 513 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395914, a Phase 3 study, has completed, sponsored by Helsinn Therapeutics (U.S.).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 513 participants
- Enrollment target
Study Summary
The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
Primary Outcome
To Evaluate the Safety and Tolerability of Anamorelin HCl.
Interventions
- DRUG Placebo
- DRUG Anamorelin HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 513 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01395914 record still lists
NCT01395914 is an interventional study that assigns participants to a tested intervention. The registered 513 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01395914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395914 about?
NCT01395914 is a clinical study titled "Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)". The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
What is the current status of trial NCT01395914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 513 participants. The study started on 2011-07. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01395914?
The interventions under investigation include: Placebo (DRUG), Anamorelin HCl (DRUG).
Who is sponsoring clinical trial NCT01395914?
This trial is sponsored by Helsinn Therapeutics (U.S.), which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395914's enrollment target sits among peer trials
513 727th of 2000 higher than 1,273 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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