Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure - Full Text View

Sponsor:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00132886

Purpose

This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: tolvaptan	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Tolvaptan

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:

Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary Outcome Measures:

Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Change in urine output and free water clearance
Change from baseline in urine osmolality
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Adverse events, vital signs and clinical labs

Estimated Enrollment:	140
Study Start Date:	December 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with Class III or IV heart failure for at least 3 months
Left ventricular ejection fraction less than or equal to 40%
Currently being treated for heart failure with standard therapies for at least one month

Exclusion Criteria:

Women who are pregnant or breastfeeding
Inability to take oral medications
Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
Hypertrophic obstructive cardiomyopathy
Severe obstructive pulmonary disease
Significant renal impairment
Significant uncorrected valvular or congenital heart disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132886

Show 31 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

Study Chair:

James Udelson, MD

Cardiovascular Clinical Studies and Tufts/New England Medical Center

More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Järvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus. J Am Coll Cardiol. 2008 Dec 16;52(25):2190-7.

Udelson JE, Orlandi C, Ouyang J, Krasa H, Zimmer CA, Frivold G, Haught WH, Meymandi S, Macarie C, Raef D, Wedge P, Konstam MA, Gheorghiade M. Acute hemodynamic effects of tolvaptan, a vasopressin V2 receptor blocker, in patients with symptomatic heart failure and systolic dysfunction: an international, multicenter, randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Nov 4;52(19):1540-5.

ClinicalTrials.gov Identifier:	NCT00132886 History of Changes
Other Study ID Numbers:	156-04-247
Study First Received:	August 18, 2005
Last Updated:	May 2, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 24, 2012