Congestive Heart FailurePhase 2NCT00652782
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
A Phase 2 study testing rolofyline in people with Congestive Heart Failure and Renal Impairment, run by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
Trial summary
A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Renal Impairment
- What is being tested?
- rolofyline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Aug 2005
- 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
- Be able to provide written informed consent,
- Be a male or female at least 18 years of age,
- Be hospitalized for fluid overload requiring IV diuretic therapy
- History of use of diuretic therapy for CHF (including this admission),
- Be admitted to the hospital within 36 hours of the mandatory dose of IV furosemide 40 mg at between 2000 and 2200 hour on Day -1
Who cannot join
- Have had a myocardial infarction within 30 days prior to Day -1
- Be pregnant or breast-feeding
- Have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy
- Have had implantation of an automated implanted cardiac defibrillator (AICD) or synchronization device within the preceding 7 days
- Currently require mechanical ventilation, ultrafiltration, or hemodialysis,
- Have symptomatic ventricular tachycardia
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- Be admitted for heart transplant surgery or have had a heart transplant,
- Have any other concomitant life-threatening disease,
- Have participated in a clinical trial of an investigational drug or device within 30 days before randomization
- Have a positive urine pregnancy test (for women of child-bearing capacity)
- Have an allergy to soybean oil and/or eggs
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of The Effects of MK7418, Both as Monotherapy and in Combination With Furosemide, On Diuresis and Renal Function in Patients With Congestive Heart Failure (CHF) And Renal Impairment Treated With Oral Loop Diuretics Who Require Hospitalization For Fluid Overload
A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.
- Conditions
- Congestive Heart Failure, Renal Impairment
- Being tested
- rolofyline, Comparator Placebo (unspecified)
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rolofylineDrug
Also called MK7418
rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
Comparator Placebo (unspecified)Drug
Matching placebo for rolofyline IV QD; 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | rolofyline 2.5 mg IV QD Receives: Drug: rolofyline |
| 2 | Experimental | rolofyline 15 mg IV QD Receives: Drug: rolofyline |
| 3 | Experimental | rolofyline 30 mg IV QD Receives: Drug: rolofyline |
| 4 | Experimental | rolofyline 60 mg IV QD Receives: Drug: rolofyline |
| 5 | Placebo comparator | placebo for rolofyline IV QD Receives: Drug: Comparator Placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment
Measured: 30 days
Secondary outcomes (1)
To determine the optimal dose range of intravenous (IV) study medication combination with IV furosemide, with or without other diuretics, in preventing deterioration of renal function in CHF patients
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startDec 2004
- Primary completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652782
- Sponsor's protocol ID
- 2007_806
- Other IDs
- MK7418-201
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of The Effects of MK7418, Both as Monotherapy and in Combination With Furosemide, On Diuresis and Renal Function in Patients With Congestive Heart Failure (CHF) And Renal Impairment Treated With Oral Loop Diuretics Who Require Hospitalization For Fluid Overload
- ClinicalTrials.gov ID
- NCT00652782
- Acronym / sponsor ID
- 2007_806
- Conditions
- Congestive Heart Failure, Renal Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2004
- Primary completion
- Aug 2005 (actual)
- First posted
- 4 Apr 2008 (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.
A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rolofylinerolofyline 2.5 mg IV QD |
| 2 | Experimental | Drug: rolofylinerolofyline 15 mg IV QD |
| 3 | Experimental | Drug: rolofylinerolofyline 30 mg IV QD |
| 4 | Experimental | Drug: rolofylinerolofyline 60 mg IV QD |
| 5 | Placebo comparator | Drug: Comparator Placebo (unspecified)placebo for rolofyline IV QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be able to provide written informed consent,
- Be a male or female at least 18 years of age,
- Be hospitalized for fluid overload requiring IV diuretic therapy
- History of use of diuretic therapy for CHF (including this admission),
- Be admitted to the hospital within 36 hours of the mandatory dose of IV furosemide 40 mg at between 2000 and 2200 hour on Day -1
Key exclusion criteria (11 listed)
- Have had a myocardial infarction within 30 days prior to Day -1
- Be pregnant or breast-feeding
- Have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy
- Have had implantation of an automated implanted cardiac defibrillator (AICD) or synchronization device within the preceding 7 days
- Currently require mechanical ventilation, ultrafiltration, or hemodialysis,
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 |
|---|---|---|
| rolofylineAlso: MK7418rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days | Drug | 1, 2, 3, 4 |
| Comparator Placebo (unspecified)Matching placebo for rolofyline IV QD; 3 days | Drug | 5 |
Primary outcome
To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment
Time frame: 30 days
1 secondary outcome
To determine the optimal dose range of intravenous (IV) study medication combination with IV furosemide, with or without other diuretics, in preventing deterioration of renal function in CHF patients
Time frame: 30 Days
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 4 Apr 2008.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rolofyline in people with Congestive Heart Failure and Renal Impairment, run by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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 5 inclusion and 11 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 4 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment (time frame: 30 days). 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 4 Apr 2008.