Status:
COMPLETED
An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Heart Decompensation
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The present study was an open-label, uncontrolled, and multi-centered phase III clinical trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of nesiritide.
Detailed Description
This was an open-label, uncontrolled, and multi-centered phase II clinical trial for evaluation of the clinical efficacy and hemodynamics and safety of nesiritide. The study was conducted in hospital ...
Eligibility Criteria
Inclusion
- Systolic blood pressure\> 90 mmHg
- The subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up)
- Onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration
- Acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia)
- The patients must have at least two of manifestations that related with this acute onset.
Exclusion
- Patients with systolic blood pressure =90 mmHg
- patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug
- Patients who had known or suspected acute coronary syndrome (Myocardial infarction with or without increased ST segment, or unstable myocardial infarction) within 2 weeks before administration of the investigational drug
- Patients with cardiac shock or clinical manifestation of uncorrected hypovolemia or sodium depletion (such as clinical signs of excessive diuresis or dehydration), or clinical manifestation induced by other forbidden venous vasoactive agents
- Patients with such extremely emergent and unstable clinical conditions that not tolerant to Swan-Ganz catheter or temporal baseline evaluation
- patients with obvious cardiac valvular stenosis (subjects treated by valve-replacement can be included), hypertrophic, restrictive, or obstructive myocardial disease, primary pulmonary hypertension, or complex congenital heart disease.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00813202
Start Date
October 1 2006
End Date
June 1 2007
Last Update
February 28 2014
Active Locations (4)
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1
Beijing, China
2
Hangzhou, China
3
Shanghai, China
4
Xi'an, China