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| ID | Type | Description | Link |
|---|---|---|---|
| B1321005 | |||
| 2006-002004-33 | EudraCT Number | ||
| FCRD01 | Other Identifier | Alias Study Number |
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This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitaxsentan | Experimental | Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) |
|
| Nifedipine | Active Comparator | Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm) |
|
| Placebo | Placebo Comparator | Placebo for sitaxsentan, orally administered once daily (double blind arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open | Drug | Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24-Hour Urine Total Protein Level at 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. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre and Pharmacology Unit | Edinburgh | Scotland | EH4 2XU | United Kingdom | ||
| the University of Edinburgh, Western General Hospital, Department of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31177906 | Derived | Farrah TE, Anand A, Gallacher PJ, Kimmitt R, Carter E, Dear JW, Mills NL, Webb DJ, Dhaun N. Endothelin Receptor Antagonism Improves Lipid Profiles and Lowers PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in Patients With Chronic Kidney Disease. Hypertension. 2019 Aug;74(2):323-330. doi: 10.1161/HYPERTENSIONAHA.119.12919. Epub 2019 Jun 10. | |
| 25801761 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Sitaxsentan Then Nifedipine | Participants received placebo matched to Sitaxsentan 100 milligram (mg) tablet orally, once daily for 6 weeks in first intervention period, then Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Nifedipine extended release (ER) 30 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| FG001 | Sitaxsentan Then Nifedipine Then Placebo | Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in first intervention period, then nifedipine ER 30 mg tablet orally, once daily for 6 weeks in second intervention period, followed by placebo matched Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| FG002 | Nifedipine Then Sitaxsentan Then Placebo | Participants received Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in first intervention period, then Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| FG003 | Nifedipine Then Placebo Then Sitaxsentan | Participants received Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in first intervention period, then placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| FG004 | Placebo Then Nifedipine Then Sitaxsentan | Participants received placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in first intervention period, then Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| FG005 | Sitaxsentan Then Placebo Then Nifedipine | Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in first intervention period, then placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in second intervention period, followed by Nifedipine ER 30 mg tablet orally, once daily for 6 weeks in third intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period (6 Weeks) |
| |||||||||||||
| First Washout Period (at Least 2 Weeks) |
| |||||||||||||
| Second Intervention Period (6 Weeks) |
| |||||||||||||
| Second Washout Period (at Least 2 Weeks) |
| |||||||||||||
| Third Intervention Period (6 Weeks) |
|
Full Analysis Set (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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who were randomized to receive Sitaxsentan 100 mg tablet, Nifedipine ER 30 mg tablet and placebo matched to Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in any intervention period. Each intervention period was separated by a washout period of at least 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean 24-Hour Urine Total Protein Level at 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. | 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. | Posted | Mean | Standard Deviation | Grams per 24 hours | Baseline, Week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitaxsentan | Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C106276 | sitaxsentan |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nifedipine | Drug | Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm) |
|
| Placebo | Drug | Placebo for sitaxsentan, orally administered once daily (double blind arm) |
|
| Baseline, Week 3 and 6 |
| Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at 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. | Baseline, Week 3 and 6 |
| Edinburgh |
| Scotland |
| EH4 2XU |
| United Kingdom |
| Dhaun N, Yuzugulen J, Kimmitt RA, Wood EG, Chariyavilaskul P, MacIntyre IM, Goddard J, Webb DJ, Corder R. Plasma pro-endothelin-1 peptide concentrations rise in chronic kidney disease and following selective endothelin A receptor antagonism. J Am Heart Assoc. 2015 Mar 23;4(3):e001624. doi: 10.1161/JAHA.114.001624. |
| 24890823 | Derived | Dhaun N, Moorhouse R, MacIntyre IM, Melville V, Oosthuyzen W, Kimmitt RA, Brown KE, Kennedy ED, Goddard J, Webb DJ. Diurnal variation in blood pressure and arterial stiffness in chronic kidney disease: the role of endothelin-1. Hypertension. 2014 Aug;64(2):296-304. doi: 10.1161/HYPERTENSIONAHA.114.03533. |
| 23243212 | Derived | Dhaun N, Melville V, Blackwell S, Talwar DK, Johnston NR, Goddard J, Webb DJ. Endothelin-A receptor antagonism modifies cardiovascular risk factors in CKD. J Am Soc Nephrol. 2013 Jan;24(1):31-6. doi: 10.1681/ASN.2012040355. Epub 2012 Dec 14. |
| 21357275 | Derived | Dhaun N, MacIntyre IM, Kerr D, Melville V, Johnston NR, Haughie S, Goddard J, Webb DJ. Selective endothelin-A receptor antagonism reduces proteinuria, blood pressure, and arterial stiffness in chronic proteinuric kidney disease. Hypertension. 2011 Apr;57(4):772-9. doi: 10.1161/HYPERTENSIONAHA.110.167486. Epub 2011 Feb 28. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Participants administered placebo matched to 100 mg tablets orally, once daily for 6 weeks in either first, second or third intervention period. |
| OG002 | Nifedipine | Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention 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 | 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. | 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. | Posted | Mean | Standard Deviation | Millimeter of Mercury (mmHg) | Baseline, Week 3 and 6 |
|
|
|
|
| Secondary | Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at 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. | 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. | Posted | Mean | Standard Deviation | Meter per second | Baseline, Week 3 and 6 |
|
|
|
|
| 0 |
| 27 |
| 13 |
| 27 |
| EG001 | Placebo | Participants administered placebo matched to 100 mg tablets orally, once daily for 6 weeks in either first, second or third intervention period. | 0 | 27 | 21 | 27 |
| EG002 | Nifedipine | Participants were administered Nifedipine 30 mg ER tablet orally, once daily for 6 weeks in either first, second or third intervention period. | 0 | 27 | 18 | 27 |
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Iritis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Balanitis candida | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Infusion site infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Mean Systemic Arterial BP: Change at Week 6 |
|
| Mean Systemic Arterial SBP :Baseline |
|
| Mean Systemic Arterial SBP: Change at Week 3 |
|
| Mean Systemic Arterial SBP: Change at Week 6 |
|
| Mean Systemic Arterial DBP: Baseline |
|
| Mean Systemic Arterial DBP: Change at Week 3 |
|
| Mean Systemic Arterial DBP: Change at Week 6 |
|
| ANCOVA |
| 0.1424 |
| LS mean difference |
| -1.92 |
| Standard Error of the Mean |
| 1.30 |
| 2-Sided |
| 95 |
| -4.50 |
| 0.66 |
| Superiority or Other (legacy) |
| Mean Systemic Arterial BP: Week 3 | ANCOVA | 0.2277 | LS mean difference | -1.58 | Standard Error of the Mean | 1.29 | 2-Sided | 95 | -4.15 | 1.00 | Superiority or Other (legacy) |
| Systolic Blood Pressure: Week 3 | ANCOVA | 0.1599 | LS mean difference | -2.56 | Standard Error of the Mean | 1.81 | 2-Sided | 95 | -6.16 | 1.03 | Superiority or Other (legacy) |
| Systolic Blood Pressure: Week 3 | ANCOVA | 0.5545 | LS mean difference | -1.07 | Standard Error of the Mean | 1.80 | 2-Sided | 95 | -4.66 | 2.52 | Superiority or Other (legacy) |
| Systolic Blood Pressure: Week 3 | ANCOVA | 0.4095 | LS mean difference | -1.49 | Standard Error of the Mean | 1.80 | 2-Sided | 95 | -5.08 | 2.09 | Superiority or Other (legacy) |
| Diastolic Blood Pressure: Week 3 | ANCOVA | 0.0012 | LS mean difference | -4.08 | Standard Error of the Mean | 1.21 | 2-Sided | 95 | -6.49 | -1.67 | Superiority or Other (legacy) |
| Diastolic Blood Pressure: Week 3 | ANCOVA | 0.0159 | LS mean difference | -2.98 | Standard Error of the Mean | 1.21 | 2-Sided | 95 | -5.38 | -0.57 | Superiority or Other (legacy) |
| Diastolic Blood Pressure: Week 3 | ANCOVA | 0.3627 | LS mean difference | -1.10 | Standard Error of the Mean | 1.21 | 2-Sided | 95 | -3.51 | 1.30 | Superiority or Other (legacy) |
| Mean Systemic Arterial BP: Week 6 | ANCOVA | 0.0057 | LS mean difference | -3.36 | Standard Error of the Mean | 1.16 | 2-Sided | 95 | -5.69 | -1.03 | Superiority or Other (legacy) |
| Mean Systemic Arterial BP: Week 6 | ANCOVA | 0.6503 | LS mean difference | -0.53 | Standard Error of the Mean | 1.16 | 2-Sided | 95 | -2.86 | 1.80 | Superiority or Other (legacy) |
| Mean Systemic Arterial BP: Week 6 | ANCOVA | 0.0183 | LS mean difference | -2.83 | Standard Error of the Mean | 1.16 | 2-Sided | 95 | -5.16 | -0.50 | Superiority or Other (legacy) |
| Systolic Blood Pressure (SBP): Week 6 | ANCOVA | 0.0726 | LS mean difference | -2.81 | Standard Error of the Mean | 1.53 | 2-Sided | 95 | -5.89 | 0.27 | Superiority or Other (legacy) |
| Systolic Blood Pressure (SBP): Week 6 | ANCOVA | 0.9661 | LS mean difference | 0.07 | Standard Error of the Mean | 1.53 | 2-Sided | 95 | -3.01 | 3.14 | Superiority or Other (legacy) |
| Systolic Blood Pressure (SBP): Week 6 | ANCOVA | 0.0656 | LS mean difference | -2.88 | Standard Error of the Mean | 1.53 | 2-Sided | 95 | -5.94 | 0.19 | Superiority or Other (legacy) |
| Diastolic Blood Pressure (DBP): Week 6 | ANCOVA | 0.0068 | LS mean difference | -3.16 | Standard Error of the Mean | 1.11 | 2-Sided | 95 | -5.39 | -0.92 | Superiority or Other (legacy) |
| Diastolic Blood Pressure (DBP): Week 6 | ANCOVA | 0.3760 | LS mean difference | -0.99 | Standard Error of the Mean | 1.11 | 2-Sided | 95 | -3.22 | 1.24 | Superiority or Other (legacy) |
| Diastolic Blood Pressure (DBP): Week 6 | ANCOVA | 0.0572 | LS mean difference | -2.16 | Standard Error of the Mean | 1.11 | 2-Sided | 95 | -4.40 | 0.07 | Superiority or Other (legacy) |
|
| Change at Week 6 |
|
| 0.9457 |
| LS mean difference |
| 0.01 |
| Standard Error of the Mean |
| 0.21 |
| 2-Sided |
| 95 |
| -0.41 |
| 0.43 |
| Superiority or Other (legacy) |
| Week 3 | ANCOVA | 0.9358 | LS mean difference | 0.02 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -0.40 | 0.44 | Superiority or Other (legacy) |
| Week 6 | ANCOVA | 0.0022 | LS mean difference | -0.64 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -1.03 | -0.25 | Superiority or Other (legacy) |
| Week 6 | ANCOVA | 0.8956 | LS mean difference | -0.03 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.41 | 0.36 | Superiority or Other (legacy) |
| Week 6 | ANCOVA | 0.0030 | LS mean difference | -0.61 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -1.00 | -0.23 | Superiority or Other (legacy) |