Trial Outcomes & Findings for Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF) (NCT NCT00843986)
NCT ID: NCT00843986
Last Updated: 2014-05-15
Results Overview
MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
TERMINATED
PHASE3
9 participants
Baseline and 72 Hours
2014-05-15
Participant Flow
Participant milestones
| Measure |
Placebo
Matching loading dose and continuous intravenous infusion for 48 hours
|
Conivaptan
20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
Completed Treatment (Infusion)
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Matching loading dose and continuous intravenous infusion for 48 hours
|
Conivaptan
n=6 Participants
20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 13.05 • n=93 Participants
|
65.8 years
STANDARD_DEVIATION 7.78 • n=4 Participants
|
62.8 years
STANDARD_DEVIATION 10.07 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 72 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 Hours, 48 Hours and 72 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 Hours, 48 Hours and Day 9Population: Study was terminated - assessment of this Outcome Measure was not performed.
Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation. MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 9Population: Study was terminated - assessment of this Outcome Measure was not performed.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48.5 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point Likert scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 Hours, 12 Hours, 24 Hours and 48 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Dyspnea is defined as the sensation of uncomfortable or difficult breathing. The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity). Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9Population: Study was terminated - assessment of this Outcome Measure was not performed.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 HoursPopulation: Study was terminated - assessment of this Outcome Measure was not performed.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Conivaptan
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
Matching loading dose and continuous intravenous infusion for 48 hours
|
Conivaptan
n=6 participants at risk
20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Cardiac disorders
Cardiac failure
|
33.3%
1/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
0.00%
0/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Matching loading dose and continuous intravenous infusion for 48 hours
|
Conivaptan
n=6 participants at risk
20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
General disorders
Infusion site erythema
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
50.0%
3/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
General disorders
Infusion site pain
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
16.7%
1/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
0.00%
0/6 • Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER