Study to Assess the Safety and Tolerability of IV Tonapof... | NCT00709865

Studies
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

NCT00709865

Sponsor

Biogen

Status

Completed

Last Update Posted

Sep 11, 2023Actual

Enrollment

420Actual

Phase

Phase 3

Conditions

Renal Insufficiency
Congestive Heart Failure

Interventions

tonapofylline
Placebo

Countries

United States
Argentina
Australia
Brazil
Bulgaria
Canada
Czechia
Finland
France
Germany
India
Israel
Italy
Netherlands
Poland
Romania
Russia
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2008Actual

Primary Completion Date

Oct 30, 2009Actual

Completion Date

Dec 31, 2009Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 10, 2015

Certification/Extension First Submitted that Passed QC Review

Dec 10, 2015

Certification/Extension First Posted Date

Jan 12, 2016Estimated

Last Update Submitted Date

Sep 4, 2023

Last Update Posted Date

Sep 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	.03 mg/kg	Drug: tonapofylline
2	Experimental	.15 mg/kg	Drug: tonapofylline
3	Experimental	.3 mg/kg	Drug: tonapofylline
4	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tonapofylline	Drug	IV	1 2 3	Adentri

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.		0-60 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previous diagnosis of heart failure.
Must have ADHF, requiring hospitalization, with clinical evidence for volume overload

Exclusion Criteria:

History of an allergic reaction to any xanthine-containing substance.
History of seizure
History of stroke
Myocardial infarction
Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
Serious systemic infection
Major surgical procedures within 30 days
Acute coronary syndrome
Cardiogenic shock
Baseline body weight >150 kg
Participation in any other investigational study of drugs or devices within 30 days prior to Screening
Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
Presence of any clinically significant condition that might interfere with optimal safe participation in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama	35801	United States

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
C505954	BG 9928
C097280	1,3-dipropyl-8-(2-(5,6-epoxy)norbornyl)xanthine