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NCT01275300 · ClinicalTrials.gov registry record · NA
Biosynthesis of PGD2 in Vivo
A NA study of Hyperlipidemia, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01275300: Completed NA study of Hyperlipidemia, sponsored by University of Pennsylvania.
NCT01275300 is a NA study of Hyperlipidemia that has completed, run by University of Pennsylvania. The registered enrollment target is 9 participants, below the 408-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01275300, a NA study of Hyperlipidemia, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigator would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin. Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis
Primary Outcome
Percentage change of area under the urinary prostaglandins concentration versus time curve (AUC) in response to niacin with or without pretreatment of aspirin was studied. This outcome measures whether aspirin instead of placebo will impact the subjects' response to niacin. The area was normalized by percentile.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Niacin
- DRUG Aspirin
Study Locations (1)
Pennsylvania
- University of Pennsylvania Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-01 |
| Phase | NA |
What the finished NCT01275300 record still lists
NCT01275300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 408-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01275300 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01275300 about?
NCT01275300 is a clinical study titled "Biosynthesis of PGD2 in Vivo". The investigator would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin. Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of ni...
What is the current status of trial NCT01275300?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2007-07. Estimated completion is 2012-01.
What conditions does trial NCT01275300 study?
This clinical trial studies the following conditions: Hyperlipidemia.
What interventions are being tested in trial NCT01275300?
The interventions under investigation include: Placebo (DRUG), Niacin (DRUG), Aspirin (DRUG).
Who is sponsoring clinical trial NCT01275300?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01275300 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hyperlipidemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01275300's enrollment target sits among peer trials
9 36th of 35 the lowest of 35 other Hyperlipidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperlipidemia 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.
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