Clinical Trials Logo
  1. Home
  2. Heart Failure, Congestive
  3. NCT00259038
  4. Details
NCT00259038 Clinical Trial

Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:
A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259038
Other study ID # 03-0-162
Secondary ID
Status Completed
Phase Phase 2
First received November 28, 2005
Last updated November 4, 2016
Start date January 2004
Est. completion date February 2006

Study information
Verified date November 2016
Source Daiichi Sankyo Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Is hospitalized with congestive heart failure (CHF)

- Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher

Exclusion Criteria:

- Has had a heart transplant

- Requires mechanical ventilation or mechanical circulatory support

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Carperitide

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in pulmonary capillary wedge pressure (PCWP) at 3 hours following initiation of study drug infusion No
See also
  Status Clinical Trial Phase
Completed NCT01357850 - A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure Phase 2
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Terminated NCT00383630 - Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure Phase 2
Completed NCT00531661 - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients N/A
Completed NCT00149435 - Cardiovascular Health Study (CHS) Events Follow-up Study
Completed NCT00241761 - Epidemiology of Depression and Heart Failure in Aging N/A
Terminated NCT00125437 - Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy N/A
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Completed NCT00094263 - Long-Term Predictors of Morbidity in Older Age N/A
Terminated NCT00357591 - Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation N/A
Completed NCT00202579 - Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure Phase 2
Completed NCT00048425 - Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. Phase 3
Completed NCT00530426 - Heart Failure Registry Phase 4
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Terminated NCT00190359 - Growth Hormone and Heart Failure N/A
Completed NCT00004562 - Occluded Artery Trial (OAT) Phase 3
Completed NCT00005265 - Natural History of Coronary Heart Disease N/A
Completed NCT02772068 - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a Early Phase 1
Completed NCT02925546 - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets Phase 1
Completed NCT01074307 - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea Phase 4