Heart Failure, CongestivePhase 2NCT00259038
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
A Phase 2 study testing Carperitide in people with Heart Failure, Congestive and Heart Decompensation, run by Daiichi Sankyo at 34 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure
- What is being tested?
- Carperitide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Jan 2004to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has had a heart transplant
- Requires mechanical ventilation or mechanical circulatory support
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States30 sites
Study site
Albany, New York
Study site
Amarillo, Texas, 79106
Study site
Baltimore, Maryland, 21201
Study site
Bay Pines, Florida, 33744
Study site
Charleston, South Carolina
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267
Study site
Cleveland, Ohio, 44195
Study site
Columbia, South Carolina
Study site
Covington, Louisiana, 70433
Study site
Gainesville, Florida, 32610
Study site
Houston, Texas, 77030
Study site
Houston, Texas, 77225
Study site
Huntsville, Alabama, 35801
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90033
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33136
Study site
Minneapolis, Minnesota, 55455
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32803
Study site
Richmond, Virginia, 23298
Study site
San Diego, California, 92103
Study site
Shreveport, Louisiana, 71103
Study site
Springfield, Illinois, 62701
Study site
St Louis, Missouri, 63110
Study site
St. Petersburg, Florida, 33707
Study site
Tacoma, Washington, 98405
Study site
Tulsa, Oklahoma
Canada4 sites
Study site
Halifax, Nova Scotia, B3H 3A7
Study site
Montreal, Quebec
Study site
Saint Foy, Quebec, G1V 4G5
Study site
Toronto, Ontario, M5G 1X5
About this study
Official title: A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure
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.
- Conditions
- Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure, Myocardiopathies, Systolic or Diastolic Left Ventricular Dysfunction
- Being tested
- Carperitide, Placebo
- Keywords
- Carperitide, Atrial Natriuretic Peptide, Treatment efficacy, Safety, Heart failure, Congestive, Pulmonary Artery Catheterization
- Medical subject headings
- Heart Failure, Cardiomyopathies, Systolic Murmurs, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarperitideDrug
Also called human recombinant atrial natriuretic peptide
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental Drug | Experimental | Not described Receives: Drug: Carperitide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pulmonary capillary wedge pressure (PCWP)
Measured: at 3 hours following initiation of study drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startJan 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biljana Pavlovic-Surjancev, MD, PhD, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259038
- Sponsor's protocol ID
- 03-0-162
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2005
- Last updated
- 8 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00259038
- Acronym / sponsor ID
- 03-0-162
- Conditions
- Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure, Myocardiopathies, Systolic or Diastolic Left Ventricular Dysfunction
- Keywords
- Carperitide, Atrial Natriuretic Peptide, Treatment efficacy, Safety, Heart failure, Congestive, Pulmonary Artery Catheterization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Drug | Experimental | Drug: Carperitide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Has had a heart transplant
- Requires mechanical ventilation or mechanical circulatory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarperitideAlso: human recombinant atrial natriuretic peptide | Drug | Experimental Drug |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in pulmonary capillary wedge pressure (PCWP)
Time frame: at 3 hours following initiation of study drug infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biljana Pavlovic-Surjancev, MD, PhD study director
Astellas Pharma US, Inc.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carperitide in people with Heart Failure, Congestive and Heart Decompensation, run by Daiichi Sankyo at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pulmonary capillary wedge pressure (PCWP) (time frame: at 3 hours following initiation of study drug infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.