Phase 3 Study to Assess The Effects of IV BG9928 in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency - Full Text View

Phase 3 Study to Assess The Effects of IV BG9928 in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency (TRIDENT-1)

This study is currently recruiting participants.

Verified by Biogen Idec, September 2008

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00709865

Purpose

The purpose of the current study is to assess the effect of BG9928 on body weight in subjects with acute decompensated heart failure (ADHF) and renal insufficiency.

Condition	Intervention	Phase
Congestive Heart Failure Renal Insufficiency	Drug: BG9928 Drug: Placebo	Phase III

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Assess The Effects of Intravenous BG9928 on Body Weight in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To assess the clinical effect of BG9928, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency. [ Time Frame: 0-180 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	July 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental .03 mg/kg	Drug: BG9928 IV
2: Experimental .15 mg/kg	Drug: BG9928 IV
3: Experimental .3 mg/kg	Drug: BG9928 IV
4: Placebo Comparator Placebo	Drug: Placebo IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709865

Contacts

Contact: Biogen Idec

cardiology@biogenidec.com

Locations

United States, California
	Recruiting
Yuba City, California, United States, 95991
United States, Kansas
	Recruiting
Wichita, Kansas, United States, 67220
United States, Oklahoma
	Recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
	Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
	Recruiting
Doylestown, Pennsylvania, United States, 18901
United States, Texas
	Recruiting
Whitney, Texas, United States
	Recruiting
Houston, Texas, United States, 77004
	Recruiting
San Antonio, Texas, United States, 78215

Sponsors and Collaborators

Biogen Idec

More Information

Responsible Party:	Biogen Idec ( Biogen Idec )
Study ID Numbers:	160HF301
Study First Received:	July 1, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00709865
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

acute decompensated heart failure
congestive heart failure
renal insufficiency
diuretic

Study placed in the following topic categories:

Body Weight
Heart Failure
Renal Insufficiency

Heart Diseases
Urologic Diseases
Kidney Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009