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NCT00435331 · ClinicalTrials.gov registry record · Phase 1
6R-BH4 Pulmonary Arterial Hypertension Study
A Phase 1 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00435331: Completed Phase 1 study, sponsored by Vanderbilt University.
NCT00435331 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00435331, a Phase 1 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4 can be added safely to current treatment for PAH and whether there is any evidence of benefit from its use. The study will take approximately one year to complete from the time recruitment begins. The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in escalating doses in addition to standard care, in subjects with pulmonary arterial hypertension (PAH). The secondary objective of the study is to evaluate change in biochemical markers of endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care. The third objective of the study is to evaluate change in biomarkers of disease progression, 6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.
Interventions
- DRUG sapropterin dihydrochloride (6R-BH4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
What the finished NCT00435331 record still lists
NCT00435331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which sapropterin dihydrochloride (6R-BH4) is the first listed.
NCT00435331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00435331 about?
NCT00435331 is a clinical study titled "6R-BH4 Pulmonary Arterial Hypertension Study". The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is ...
What is the current status of trial NCT00435331?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2008-03. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00435331?
The interventions under investigation include: sapropterin dihydrochloride (6R-BH4) (DRUG).
Who is sponsoring clinical trial NCT00435331?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00435331's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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