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NCT01420068 · ClinicalTrials.gov registry record
52-104 Week Off-therapy Second Extension to Study CSPP100A2365
A clinical trial of Hypertension, sponsored by Noden Pharma.
- Completed
- Registry status
- 106
- Enrollment target
- 20
- Study locations
NCT01420068: Completed study of Hypertension, sponsored by Noden Pharma.
NCT01420068 is a study of Hypertension that has completed, run by Noden Pharma. The registered enrollment target is 106 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420068, a study of Hypertension, has completed, sponsored by Noden Pharma.
- COMPLETED
- Registry status
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and development in pediatric hypertensive patients previously treated with aliskiren in studies SPP100A2365 and SPP100A2365E1
Primary Outcome
Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 (\[Week 104\] only for participants identified in the core study as having primary hypertension), and LT Visit 19 (\[Week 156\] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.
Conditions Studied
Interventions
- DRUG SPP100
Study Locations (20)
Other
- Novartis Investigative Site - Guatemala City
- Novartis Investigative Site - Budapest
- Novartis Investigative Site - Nyíregyháza
- Novartis Investigative Site - Szeged
- Novartis Investigative Site - Veszprém
- Novartis Investigative Site - Warsaw
- Novartis Investigative Site - San Juan
- Novartis Investigative Site - Bratislava
- Novartis Investigative Site - Martin
Mississippi
- Novartis Investigative Site - Hattiesburg
- Novartis Investigative Site - Jackson
Oregon
- Novartis Investigative Site - Portland
- Novartis Investigative Site - Portland
Alabama
- Novartis Investigative Site - Birmingham
Arkansas
- Novartis Investigative Site - Little Rock
Georgia
- Novartis Investigative Site - Dalton
Idaho
- Novartis Investigative Site - Lewiston
New York
- Novartis Investigative Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2011-08-19 |
| Est. Completion | 2017-08-03 |
What the finished NCT01420068 record still lists
NCT01420068 is an observational study that tracks outcomes without assigning an intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which SPP100 is the first listed.
NCT01420068 names 20 study sites across 10 states, led by Other, Mississippi, Oregon.
Frequently Asked Questions
What is clinical trial NCT01420068 about?
NCT01420068 is a clinical study titled "52-104 Week Off-therapy Second Extension to Study CSPP100A2365". 52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and development in pediatric hypertensive patients previously treated with aliskiren in studies SPP100A2365 and SPP100A2365E1
What is the current status of trial NCT01420068?
This trial is currently completed. The enrollment target is 106 participants. The study started on 2011-08-19. Estimated completion is 2017-08-03.
What conditions does trial NCT01420068 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT01420068?
The interventions under investigation include: SPP100 (DRUG).
Who is sponsoring clinical trial NCT01420068?
This trial is sponsored by Noden Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01420068 being conducted?
This trial has 20 study locations across Alabama, Arkansas, Georgia, Idaho, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01420068's enrollment target sits among peer trials
106 288th of 470 higher than 183 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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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