Phase 3 Peripheral Arterial Disease Trial, Terminated NCT01132547 Sponsor: University of South Florida Condition: Peripheral Arterial Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT01132547) enrolled 22 people in total — 9 in the group receiving cyproheptadine hydrochloride (a medication) and 13 in the group receiving a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in body weight over 8 weeks in participants who were losing weight, comparing those who received the medication against those who received the placebo. Not everyone finished the trial: 5 of the 9 people in the medication group completed it, compared with 12 of the 13 in the placebo group. The reported data shows two primary things were measured. First, the number of participants who lost 5% or more of their body weight by the 8-week mark: 0 out of 9 in the medication group and 2 out of 13 in the placebo group met this threshold. Second, the change in a weight "Z score" (a number that compares a person's weight to what is typical for their age and size) from the start to the end of the trial: the medication group's Z score increased by 0.12 on average, while the placebo group's Z score decreased by 0.02 on average. For the secondary outcome — actual change in body weight in kilograms — the reported data shows the medication group gained an average of 0.18 kg, while the placebo group lost an average of 0.32 kg. It is worth noting that this was a very small trial, with only 22 participants at the start and even fewer completing it, which means the numbers above reflect a limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Peripheral Arterial Disease Trial, Terminated

NCT01132547
Terminated Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 2 and 21 years old when joining the study
  • You are scheduled to receive chemotherapy for a newly diagnosed cancer, including certain soft tissue sarcomas, rhabdomyosarcoma, bone cancer (osteosarcoma), Ewing's sarcoma, neuroblastoma, Wilms' tumor (Stage III/IV), liver cancer (hepatoblastoma, Stage III/IV), germ cell tumors (Stage III/IV), certain brain tumors, or a blood cancer called AML
  • You have a cancer that has come back or stopped responding to treatment (any type)
  • You are able to join the study within 28 days of starting chemotherapy

Who may not be able to join:

  • You started chemotherapy more than 28 days ago
  • You have lost 5% or more of your body weight unintentionally in the last 3 months, thought to be related to cancer
  • You are currently taking, or have taken in the last 3 weeks, a medication called cyproheptadine
  • You have a history of eating disorders such as anorexia nervosa or bulimia
  • You have taken appetite-stimulating medications such as dronabinol (Marinol) in the past 3 weeks
  • You are taking or plan to take other medications or treatments to increase appetite or cause weight gain, including certain steroids or tube feeding
  • You have been taking steroids as part of your cancer treatment for more than 7 days (short-term steroid use for nausea is allowed)
  • You are taking certain medications including MAO inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil)
  • You have been diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or a blockage in your digestive or urinary system
  • You have a known allergy to cyproheptadine
  • You are female and currently pregnant
  • You are female and breastfeeding, unless you agree to stop breastfeeding during the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Terminated
Phase
Phase 3
Sponsor
University of South Florida
Registry
ClinicalTrials.gov
Start date
1 June 2010
Est. completion
1 January 2014

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline; Severity of Weight Loss

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov