Trial · NCT02166697
Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
NCT02166697, Completed, Takeda; results first posted 2016-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome". Trials, record NCT02166697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02166697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
- NCT number
- NCT02166697
- Status
- Completed
- Enrollment
- 14,151 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- candesartan cilexetil
- First posted
- 2014-06-18
- Last updated
- 2016-09-28
- Results first posted
- 2016-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | Baseline up to 3 years | ADR are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. |
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | Baseline up to 3 years | SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events | Baseline up to 3 years | Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Baseline up to 3 years | Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Baseline up to 3 years | Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
| Secondary | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Baseline up to 3 years | Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | Baseline up to 3 years | The safety analysis set was defined as all participants who were enrolled and completed the study. | Participants | NUMBER |
| PRIMARY | Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | Baseline up to 3 years | The safety analysis set was defined as all participants who were enrolled and completed the study. | Participants | NUMBER |
| SECONDARY | Incidence of Cerebrovascular/Cardiovascular Events | Baseline up to 3 years | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Number of events per 1,000 person-years | NUMBER |
| SECONDARY | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities | Baseline up to 3 years | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Number of events/1,000 person-years | NUMBER |
| SECONDARY | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities | Baseline up to 3 years | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Number of events/1,000 person-years | NUMBER |
| SECONDARY | Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities | Baseline up to 3 years | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Number of events/1,000 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions (ADR) | Candesartan Cilexetil | 230 | Participants | ||
| Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR) | Candesartan Cilexetil | 320 | Participants | ||
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Sudden Death | 0.24 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Cerebral Hemorrhage | 0.57 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Cerebral Infarction | 2.34 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Subarachnoid Hemorrhage | 0.15 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Acute Myocardial Infarction | 0.99 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Hospitalization for Heart Failure | 0.27 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Intervention/Hospitalization for Angina Pectoris | 1.74 | Number of events per 1,000 person-years | |
| Incidence of Cerebrovascular/Cardiovascular Events | Candesartan Cilexetil | Atrial Fibrillation | 1.35 | Number of events per 1,000 person-years |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Candesartan Cilexetil | 14,151 | |
| Overall Study | COMPLETED | Candesartan Cilexetil | 13,804 | |
| Overall Study | NOT COMPLETED | Candesartan Cilexetil | 347 |
Source ClinicalTrials.gov
Adverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute myocardial infarction | Cardiac disorders | Candesartan Cilexetil | 3 | 13,804 | |
| other | Angina pectoris | Cardiac disorders | Candesartan Cilexetil | 5 | 13,804 | |
| other | Arrhythmia | Cardiac disorders | Candesartan Cilexetil | 1 | 13,804 | |
| other | Atrial fibrillation | Cardiac disorders | Candesartan Cilexetil | 7 | 13,804 | |
| other | Bradycardia | Cardiac disorders | Candesartan Cilexetil | 1 | 13,804 | |
| other | Cardiac failure | Cardiac disorders | Candesartan Cilexetil | 1 | 13,804 | |
| other | Palpitations | Cardiac disorders | Candesartan Cilexetil | 4 | 13,804 | |
| other | Sick sinus syndrome | Cardiac disorders | Candesartan Cilexetil | 1 | 13,804 | |
| other | Supraventricular extrasystoles | Cardiac disorders | Candesartan Cilexetil | 1 | 13,804 | |
| other | Ventricular extrasystoles | Cardiac disorders | Candesartan Cilexetil | 1 | 13,804 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Candesartan Cilexetil | ||
| Total, other adverse events | Candesartan Cilexetil | 230 | 13,804 |
| Total, serious adverse events | Candesartan Cilexetil | 320 | 13,804 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02166697
GET https://conductscience.org/api/trials/v1/NCT02166697/results?page=2