A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure - Full Text View

Purpose

The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.

Condition	Intervention	Phase
Diastolic Heart Failure	Drug: Sitaxsentan sodium Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2 Randomised, Double-Blind, Placebo-Controlled Exploratory Efficacy Study Of Sitaxsentan Sodium To Improve Impaired Exercise Tolerance In Subjects With Diastolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

change in treadmill exercise time from baseline [ Time Frame: Baseline and month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the ratio of E/E' measured by Doppler ECHO and TDI [ Time Frame: Baseline and month 24 ] [ Designated as safety issue: No ]
Change in left ventricular mass measured by ECHO [ Time Frame: Baseline and month 24 ] [ Designated as safety issue: No ]
Change in Quality of Life Assessment as measured by the MLHF [ Time Frame: Baseline and month 24 ] [ Designated as safety issue: No ]
Change in NYHA Functional Class [ Time Frame: Baseline and month 24 ] [ Designated as safety issue: Yes ]

Enrollment:	192
Study Start Date:	March 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sitaxsentan sodium	Drug: Sitaxsentan sodium sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months
Placebo Comparator: Placebo	Drug: Placebo placebo identical to the study drug in description, dose and duration

Arms

Assigned Interventions

Experimental: Sitaxsentan sodium

Drug: Sitaxsentan sodium

sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months

Placebo Comparator: Placebo

Drug: Placebo

placebo identical to the study drug in description, dose and duration

Eligibility

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

Criteria

Inclusion Criteria:

18 or older with chronic heart failure and evidence of diastolic dysfunction on echocardiogram, heart imaging, and a minimum exercise tolerance average time of 120 seconds on two treadmill tests within 2 weeks of enrollment

Exclusion Criteria:

unstable cardiovascular disease within 4 weeks of screening, history of heart attack, cardiac by-pass surgery or percutaneous intervention, stent placement, within 3 months of screening or amyloidosis, hypertrophic obstructive or restrictive cardiomyopathy, or constrictive pericarditis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303498

Show 47 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00303498 History of Changes
Other Study ID Numbers:	B1321006, FDHF01
Study First Received:	March 16, 2006
Last Updated:	October 8, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013