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| ID | Type | Description | Link |
|---|---|---|---|
| GRH01 |
Not provided
Not provided
Not provided
See termination reason in detailed description.
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The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| ARM 1 | Experimental |
| |
| ARM 2 | Experimental |
| |
| ARM 3 | Experimental |
| |
| ARM 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo tablet once daily for 12 weeks |
| |
| TBC3711 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Blood Pressure (BP) Increase | BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values. | Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 |
| Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account. | Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting Systolic Blood Pressure (SBP) | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study. |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35294-2041 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase. |
| FG001 | TBC3711 10 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo Run-in Phase: Up to Week 2 |
|
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| Drug |
10 mg tablets once daily for 10 weeks |
|
| TBC3711 | Drug | 50 mg tablet once daily for 10 weeks |
|
| TBC3711 | Drug | 100 mg tablet once daily for 10 weeks |
|
| TBC3711 | Drug | 200 mg tablet once daily for 10 weeks |
|
| Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| Standing Systolic Blood Pressure (SBP) | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study. | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| Sitting Diastolic Blood Pressure (DBP) | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study. | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| Standing Diastolic Blood Pressure (DBP) | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study. | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | Pre-Dose and 2 hours Post-Dose on Week 10 |
| Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | Pre-Dose and 2 hours Post-Dose on Week 10 |
| Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | Pre-Dose and 2 hours Post-Dose on Week 10 |
| Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | Pre-Dose and 2 hours Post-Dose on Week 10 |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30309 | United States |
| Pfizer Investigational Site | Augusta | Georgia | 30904 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Pfizer Investigational Site | Albany | New York | 12206 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73132-4904 | United States |
| Pfizer Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| Pfizer Investigational Site | Germantown | Tennessee | 38138 | United States |
| Pfizer Investigational Site | Carroltown | Texas | 75006 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75235 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98133 | United States |
| FG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| FG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| FG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Phase: Week 3 Up to Week 12 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase. |
| BG001 | TBC3711 10 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| BG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| BG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| BG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Maximum Blood Pressure (BP) Increase | BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values. | Safety analysis set included all participants who received at least 1 dose of study treatment. Here "n" signifies participants evaluable for specified category for each treatment arm, respectively. | Posted | Least Squares Mean | Standard Error | millimeter of mercury (mmHg) | Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account. | Safety analysis set: all participants who received at least 1 dose of study treatment. "N"(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sitting Systolic Blood Pressure (SBP) | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study. | Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively. | Posted | Mean | Standard Error | mmHg | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Standing Systolic Blood Pressure (SBP) | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study. | FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively. | Posted | Mean | Standard Error | mmHg | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sitting Diastolic Blood Pressure (DBP) | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study. | FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively. | Posted | Mean | Standard Error | mmHg | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Standing Diastolic Blood Pressure (DBP) | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study. | FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here "N" (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively. | Posted | Mean | Standard Error | mmHg | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mmHg | Pre-Dose and 2 hours Post-Dose on Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mmHg | Pre-Dose and 2 hours Post-Dose on Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mmHg | Pre-Dose and 2 hours Post-Dose on Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. | FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. "N" (number of participants analyzed): participants evaluable for this measure. | Posted | Least Squares Mean | Standard Error | mmHg | Pre-Dose and 2 hours Post-Dose on Week 10 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase. | 0 | 10 | 4 | 10 | ||
| EG001 | TBC3711 10 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. | 0 | 8 | 3 | 8 | ||
| EG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. | 1 | 11 | 3 | 11 | ||
| EG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. | 1 | 10 | 4 | 10 | ||
| EG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. | 0 | 10 | 5 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemiparesis | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dyspnoea | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
Results for 'change from standing to sitting SBP and DBP' and 'change from pre-dose to post-dose SBP and DBP' are reported only at Week 10 as per changes in planned analysis because of early termination of the study and clinical development program.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C485107 | N-(2-acetyl-4,6-dimethylphenyl)-3-(3,4-dimethylisoxazol-5-ylsulfamoyl)thiophene-2-carboxamide |
Not provided
Not provided
Not provided
| Participant Defaulted |
|
| Other |
|
| 45 to 64 Years |
|
| Greater Than or Equal to (>=) 65 Years |
|
| Male |
|
| Standing SBP (n= 10, 8, 11, 10, 10) |
|
| Sitting DBP (n= 8, 6, 9, 8, 8) |
|
| Standing DBP (n= 10, 8, 11, 10, 10) |
|
Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.
| ANCOVA |
| 0.970 |
| LS Mean Difference |
| 0.21 |
| Standard Error of the Mean |
| 5.59 |
| 2-Sided |
| 95 |
| -11.16 |
| 11.59 |
| No |
| Superiority or Other |
| Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.994 | LS Mean Difference | -0.04 | Standard Error of the Mean | 5.71 | 2-Sided | 95 | -11.66 | 11.57 | No | Superiority or Other |
| Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.861 | LS Mean Difference | 1.01 | Standard Error of the Mean | 5.72 | 2-Sided | 95 | -10.62 | 12.64 | No | Superiority or Other |
| Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.221 | LS Mean Difference | 6.10 | Standard Error of the Mean | 4.90 | 2-Sided | 95 | -3.79 | 15.99 | No | Superiority or Other |
| Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.880 | LS Mean Difference | 0.68 | Standard Error of the Mean | 4.49 | 2-Sided | 95 | -8.37 | 9.73 | No | Superiority or Other |
| Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.900 | LS Mean Difference | -0.57 | Standard Error of the Mean | 4.56 | 2-Sided | 95 | -9.78 | 8.63 | No | Superiority or Other |
| Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.218 | LS Mean Difference | -5.71 | Standard Error of the Mean | 4.56 | 2-Sided | 95 | -14.91 | 3.50 | No | Superiority or Other |
| Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.044 | LS Mean Difference | 5.62 | Standard Error of the Mean | 2.68 | 2-Sided | 95 | 0.17 | 11.08 | No | Superiority or Other |
| Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.557 | LS Mean Difference | 1.43 | Standard Error of the Mean | 2.41 | 2-Sided | 95 | -3.47 | 6.33 | No | Superiority or Other |
| Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.016 | LS Mean Difference | 6.37 | Standard Error of the Mean | 2.50 | 2-Sided | 95 | 1.28 | 11.45 | No | Superiority or Other |
| Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.695 | LS Mean Difference | 0.99 | Standard Error of the Mean | 2.50 | 2-Sided | 95 | -4.09 | 6.07 | No | Superiority or Other |
| Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.067 | LS Mean Difference | 4.80 | Standard Error of the Mean | 2.56 | 2-Sided | 95 | -0.36 | 9.95 | No | Superiority or Other |
| Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.737 | LS Mean Difference | 0.80 | Standard Error of the Mean | 2.36 | 2-Sided | 95 | -3.96 | 5.55 | No | Superiority or Other |
| Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.023 | LS Mean Difference | 5.64 | Standard Error of the Mean | 2.40 | 2-Sided | 95 | 0.80 | 10.47 | No | Superiority or Other |
| Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate. | ANCOVA | 0.495 | LS Mean Difference | 1.65 | Standard Error of the Mean | 2.40 | 2-Sided | 95 | -3.20 | 6.50 | No | Superiority or Other |
| TBC3711 50 mg |
Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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| OG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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| OG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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| OG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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| OG002 | TBC3711 50 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. |
| OG003 | TBC3711 100 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. |
| OG004 | TBC3711 200 mg | Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. |
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