Trial · NCT00810732

Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects

NCT00810732, Phase 2, Completed, Pfizer; results first posted 2023-07-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects. Trials, record NCT00810732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00810732

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects
NCT number: NCT00810732
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Pfizer
Conditions: Chronic Kidney Disease
Interventions: Open, Nifedipine, Placebo
First posted: 2008-12-18
Last updated: 2023-07-06
Other registries' IDs: eudract:2006-002004-33
Results first posted: 2023-07-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Baseline, Week 6	Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.
Secondary	Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Baseline, Week 3 and 6	The 24-hour ambulatory BP monitoring was performed by using a BP cuff which was attached to the participant's arm, using the same arm throughout the study, with a small monitor that comfortably sits in the pocket of participant. Mean values over 24-hour measurements at each measurement period were calculated. The change in total 24-hour ambulatory monitoring of systemic arterial BP, SBP and DBP at Week 3 and 6 relative to baseline were reported. Baseline was as an average of the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.
Secondary	Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6	Baseline, Week 3 and 6	Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Baseline was defined as the pre-dose measurement for the measure collected at Week 0 of each treatment period. Week 3 and Week 6 was an average of measurement for the measure collected at Week 3 and 6 of each treatment period.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Baseline, Week 6	FAS included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.	Grams per 24 hours	MEAN
SECONDARY	Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Baseline, Week 3 and 6	FAS included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.	Millimeter of Mercury (mmHg)	MEAN
SECONDARY	Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6	Baseline, Week 3 and 6	FAS included all participants who received at least one dose of study drug and had received at least 1 on-treatment assessment for at least 1 endpoint.	Meter per second	MEAN

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Sitaxsentan	Baseline	2.07	Standard Deviation 1.77	Grams per 24 hours
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Placebo	Baseline	2.07	Standard Deviation 1.96	Grams per 24 hours
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Nifedipine	Baseline	1.95	Standard Deviation 1.58	Grams per 24 hours
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Sitaxsentan	Change at week 6	-0.62	Standard Deviation 0.56	Grams per 24 hours
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Placebo	Change at week 6	-0.06	Standard Deviation 0.89	Grams per 24 hours
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6	Nifedipine	Change at week 6	0.01	Standard Deviation 0.77	Grams per 24 hours
Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Sitaxsentan	Mean Systemic Arterial BP: Baseline	92.94	Standard Deviation 7.39	Millimeter of Mercury (mmHg)
Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Placebo	Mean Systemic Arterial BP: Baseline	92.98	Standard Deviation 9.33	Millimeter of Mercury (mmHg)
Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Nifedipine	Mean Systemic Arterial BP: Baseline	93.78	Standard Deviation 8.35	Millimeter of Mercury (mmHg)
Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6	Sitaxsentan	Mean Systemic Arterial BP: Change at Week 3	-4.59	Standard Deviation 5.02	Millimeter of Mercury (mmHg)

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow90

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention Period (6 Weeks)	STARTED	Placebo Then Sitaxsentan Then Nifedipine	5
First Intervention Period (6 Weeks)	STARTED	Sitaxsentan Then Nifedipine Then Placebo	4
First Intervention Period (6 Weeks)	STARTED	Nifedipine Then Sitaxsentan Then Placebo	4
First Intervention Period (6 Weeks)	STARTED	Nifedipine Then Placebo Then Sitaxsentan	5
First Intervention Period (6 Weeks)	STARTED	Placebo Then Nifedipine Then Sitaxsentan	5
First Intervention Period (6 Weeks)	STARTED	Sitaxsentan Then Placebo Then Nifedipine	4
First Intervention Period (6 Weeks)	COMPLETED	Placebo Then Sitaxsentan Then Nifedipine	5
First Intervention Period (6 Weeks)	COMPLETED	Sitaxsentan Then Nifedipine Then Placebo	4
First Intervention Period (6 Weeks)	COMPLETED	Nifedipine Then Sitaxsentan Then Placebo	4
First Intervention Period (6 Weeks)	COMPLETED	Nifedipine Then Placebo Then Sitaxsentan	5

1 to 10 of 90Source ClinicalTrials.gov

See all 90 participant flow

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Ear pain	Ear and labyrinth disorders	Sitaxsentan	0	27
other	Ear pain	Ear and labyrinth disorders	Placebo	1	27
other	Ear pain	Ear and labyrinth disorders	Nifedipine	0	27
other	Conjunctivitis	Eye disorders	Sitaxsentan	1	27
other	Conjunctivitis	Eye disorders	Placebo	0	27
other	Conjunctivitis	Eye disorders	Nifedipine	1	27
other	Eye disorder	Eye disorders	Sitaxsentan	0	27
other	Eye disorder	Eye disorders	Placebo	0	27
other	Eye disorder	Eye disorders	Nifedipine	1	27
other	Iritis	Eye disorders	Sitaxsentan	0	27

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sitaxsentan
Total, all-cause mortality	Placebo
Total, all-cause mortality	Nifedipine
Total, other adverse events	Sitaxsentan	13	27
Total, other adverse events	Placebo	21	27
Total, other adverse events	Nifedipine	18	27
Total, serious adverse events	Sitaxsentan	0	27
Total, serious adverse events	Placebo	0	27
Total, serious adverse events	Nifedipine	0	27

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21357275	DERIVED	PubMed
23243212	DERIVED	PubMed
24890823	DERIVED	PubMed
25801761	DERIVED	PubMed
31177906	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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