A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00303498

Collaborator

(none)

192

Enrollment

Locations

Arms

Duration (Months)

4.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diastolic Heart Failure	Drug: Sitaxsentan sodium Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

change in treadmill exercise time from baseline [Baseline and month 24]

Secondary Outcome Measures

Change in the ratio of E/E' measured by Doppler ECHO and TDI [Baseline and month 24]
Change in left ventricular mass measured by ECHO [Baseline and month 24]
Change in Quality of Life Assessment as measured by the MLHF [Baseline and month 24]
Change in NYHA Functional Class [Baseline and month 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35294
2	Pfizer Investigational Site	Mobile	Alabama	United States	36608
3	Pfizer Investigational Site	Little Rock	Alaska	United States	72205
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85013
5	Pfizer Investigational Site	Tucson	Arizona	United States	85715
6	Pfizer Investigational Site	Little Rock	Arkansas	United States	72205
7	Pfizer Investigational Site	Los Angeles	California	United States	90033
8	Pfizer Investigational Site	Orange	California	United States	92868
9	Pfizer Investigational Site	Sacramento	California	United States	95825
10	Pfizer Investigational Site	San Diego	California	United States	92103-8411
11	Pfizer Investigational Site	New Haven	Connecticut	United States	06510
12	Pfizer Investigational Site	Washington	District of Columbia	United States	20011
13	Pfizer Investigational Site	Orlando	Florida	United States	32803
14	Pfizer Investigational Site	Chicago	Illinois	United States	60637
15	Pfizer Investigational Site	Peoria	Illinois	United States	61606
16	Pfizer Investigational Site	Auburn	Maine	United States	04210
17	Pfizer Investigational Site	Boston	Massachusetts	United States	02114
18	Pfizer Investigational Site	Boston	Massachusetts	United States	02115
19	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55417-2309
20	Pfizer Investigational Site	St. Louis	Missouri	United States	63110
21	Pfizer Investigational Site	Lincoln	Nebraska	United States	68526
22	Pfizer Investigational Site	Manchester	New Hampshire	United States	03102
23	Pfizer Investigational Site	Newark	New Jersey	United States	07112
24	Pfizer Investigational Site	Buffalo	New York	United States	14221-5838
25	Pfizer Investigational Site	New York	New York	United States	10032
26	Pfizer Investigational Site	Troy	New York	United States	112180
27	Pfizer Investigational Site	Charlotte	North Carolina	United States	28204-3288
28	Pfizer Investigational Site	Huntersville	North Carolina	United States	28078
29	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27157-1045
30	Pfizer Investigational Site	Columbus	Ohio	United States	43210-1252
31	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73120
32	Pfizer Investigational Site	Portland	Oregon	United States	97220
33	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19104
34	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19140
35	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19141
36	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15212
37	Pfizer Investigational Site	Charleston	South Carolina	United States	29401
38	Pfizer Investigational Site	Rapid City	South Dakota	United States	57701
39	Pfizer Investigational Site	Germantown	Tennessee	United States	38138
40	Pfizer Investigational Site	Houston	Texas	United States	77030
41	Pfizer Investigational Site	Murray	Utah	United States	84157
42	Pfizer Investigational Site	Salt Lake City	Utah	United States	84132
43	Pfizer Investigational Site	Burlington	Vermont	United States	05401
44	Pfizer Investigational Site	Richmond	Virginia	United States	23298
45	Pfizer Investigational Site	Madison	Wisconsin	United States	53792
46	Pfizer Investigational Site	Toronto	Ontario	Canada	M5B1W8
47	Pfizer Investigational Site	Montreal	Quebec	Canada	H3T 1E2

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00303498

Other Study ID Numbers:

B1321006
FDHF01

First Posted:

Mar 17, 2006

Last Update Posted:

Oct 11, 2012

Last Verified:

Oct 1, 2012

Additional relevant MeSH terms:

Heart Failure

Heart Failure, Diastolic

Sitaxsentan

Study Results

No Results Posted as of Oct 11, 2012