← Human Trials & Peer-Reviewed Studies
Natrecor in Pulmonary Hypertension
Plain-language guide to NCT00075179: phase 4 interventional trial of BNP (Nesiritide), 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00075179
- Phase
- phase 4
- Status
- terminated early
- Start
- 2003-12-31
- Completion (planned or actual)
- 2006-03-28
- Participants
- 15 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Pulmonary Hypertension; Cancer; Lung Disease; Cardiothoracic Surgery
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around BNP (Nesiritide).
It had 1 arm (groups): Nesiritide (experimental).
The registry classes the interventions as drug and procedure.
More on the Plan
Patients with high pressure in their lungs often have many symptoms such as, shortness of breath, low energy, and fatigue.
Before treatment, you will be asked questions about your medical history and about any medications you are currently taking.
You will have a focused physical exam.
You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart).
Who Took Part
Enrollment: 15 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Ages 18 to 85 years old. Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's). PHTN documented by Doppler Echocardiography ( Done with in last 30 days). Must be able to give an informed consent.
The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: active infection or sepsis as defined by fever and need for iv antibiotics; severe thrombocytopenia (as defined by platelets less than 20,000 or inr \> 1.6; hypersensitivity to nesiritide or any of it's components.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label BNP (Nesiritide) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2003-12-31 with completion listed for 2006-03-28.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4 trial of BNP (Nesiritide) in 15 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the BNP (Nesiritide) compound page, all human trials.
Our Notes on the Compound
BNP (Nesiritide): B-type natriuretic peptide, a 32-amino-acid heart hormone; nesiritide (Natrecor) is a recombinant form used in acute heart failure.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.