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In this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.
All the subjects whom an investigator prescribes Amlodipine (Norvasc®) 10mg Tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine 10mg Tablet | Subjects taking Amlodipine 10mg Tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose. Dosage should be adjusted depending on the patient's symptoms. The dose can be raised up to 10 mg once daily for patients who show inadequate response. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.). | Last day of observation period (average of 14.76 weeks) |
| The Achievement Rate to Ambulatory Blood Pressure Goal | The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
| Changes in Ambulatory Systolic Blood Pressure From Baseline | Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
| Changes in Ambulatory Diastolic Blood Pressure From Baseline | Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Listed in Japanese Package Insert | Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values). |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects who have been treated with amlodipine 5mg at least 4 weeks and had not achieved target BP.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| 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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A total of 14141 participants were registered in the study. Of the 14141 participants, 366 participants were excluded from the study because their case report forms were not collected, mainly due to the lack of cooperation from the investigators. Finally, 13775 participants were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine 10 mg Tablet | Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 13775 participants completed the survey. Of the 13775 participants, a total of 432 participants were excluded from the baseline analysis for the following reasons: no visit after first day of treatment, lost to follow up, contract deviation, centralized registration deviation and no drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine 10 mg Tablet | Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Treatment Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.). | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | participants | Last day of observation period (average of 14.76 weeks) |
|
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The frequency of adverse events during the study.
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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 | Amlodipine 10 mg Tablet | Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| 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 |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Last day of observation period (average of 14.76 weeks) |
| Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.). | Last day of observation period (average of 14.76 weeks) |
| Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) | To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants With Treatment-Related Adverse Events: Male vs. Female | To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) | To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) | To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) | To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) | To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) | To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) | To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) | To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) | To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) |
| Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) |
| The Achievement Rate to Home Blood Pressure Goal | The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
| Changes in Home Systolic Blood Pressure From Baseline | Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
| Changes in Home Diastolic Blood Pressure From Baseline | Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
| No visit after first day of treatment |
|
| No drug administration |
|
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | The Achievement Rate to Ambulatory Blood Pressure Goal | The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
|
|
|
| Primary | Changes in Ambulatory Systolic Blood Pressure From Baseline | Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Mean | Standard Deviation | mmHg | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Primary | Changes in Ambulatory Diastolic Blood Pressure From Baseline | Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Mean | Standard Deviation | mmHg | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants With Adverse Events Listed in Japanese Package Insert | Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values). | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
| Secondary | Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.). | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Events | Last day of observation period (average of 14.76 weeks) |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) | To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction. | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events: Male vs. Female | To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events. | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) | To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events. | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) | To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events. | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) | To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events. | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) | To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events. | The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) | To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) | To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) | To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) | To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | Participants | Last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | The Achievement Rate to Home Blood Pressure Goal | The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
|
|
|
| Secondary | Changes in Home Systolic Blood Pressure From Baseline | Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Mean | Standard Deviation | mmHg | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
|
|
|
|
| Secondary | Changes in Home Diastolic Blood Pressure From Baseline | Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement. | Posted | Mean | Standard Deviation | mmHg | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) |
|
|
|
|
| 78 |
| 13,343 |
| 250 |
| 13,343 |
| Meningitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Intracranial haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aphagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 15.1 | 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.
|
| Week 12 |
|
|
| Last Day |
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|
|
| Week 12 |
|
|
| Last Day |
|
|
The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.
| t-test, 1 sided |
A one-sided paired t-test was performed to test the hypothesis. |
| <0.001 |
Week 8 |
| Superiority or Other (legacy) |
| The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Week 12 | Superiority or Other (legacy) |
| The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Last Day | Superiority or Other (legacy) |
|
| Week 12 |
|
|
| Last Day |
|
|
The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0. |
| t-test, 1 sided |
A one-sided paired t-test was performed to test the hypothesis. |
| <0.001 |
Week 8 |
| Superiority or Other (legacy) |
| The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Week 12 | Superiority or Other (legacy) |
| The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Last Day | Superiority or Other (legacy) |
|
| Week 12 |
|
|
| Last Day |
|
|
|
| Week 12 |
|
|
| Last Day |
|
|
The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.
| t-test, 1 sided |
A one-sided paired t-test was performed to test the hypothesis. |
| <0.001 |
Week 8 |
| Superiority or Other (legacy) |
| The null hypothesis was that the mean change in home SBP from the baseline was equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Week 12 | Superiority or Other (legacy) |
| The null hypothesis was that the mean change in home SBP from the baseline was equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Last Day | Superiority or Other (legacy) |
|
| Week 12 |
|
|
| Last Day |
|
|
The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.
| t-test, 1 sided |
A one-sided paired t-test was performed to test the hypothesis. |
| <0.001 |
Week 8 |
| Superiority or Other (legacy) |
| The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Week 12 | Superiority or Other (legacy) |
| The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0. | t-test, 1 sided | A one-sided paired t-test was performed to test the hypothesis. | <0.001 | Last Day | Superiority or Other (legacy) |