Trial · NCT02211638
Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」
NCT02211638, Completed, Takeda; results first posted 2018-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」. Trials, record NCT02211638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02211638
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」
- NCT number
- NCT02211638
- Status
- Completed
- Enrollment
- 18,113 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- Candesartan Cilexetil
- First posted
- 2014-08-07
- Last updated
- 2018-11-05
- Results first posted
- 2018-11-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Clinic Blood Pressure in the Sitting Position | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported. |
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported. |
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. |
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | Baseline and Last dose of ARB Combination Drug (up to Month 6) | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. |
| Primary | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14 | Baseline and Last dose of ARB Combination Drug (up to Month 6) | Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care. |
| Secondary | Number of Participants Who Experience at Least One Adverse Drug Reactions | Up to Month 3 | Adverse drug reactions 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. |
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 | Changes in Clinic Blood Pressure in the Sitting Position | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was all participants in safety analysis set who were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint. | mmHg | MEAN |
| PRIMARY | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Baseline, Month 3 and Last dose of Candesartan (up to Month 6) | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who continued candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint. | mmHg | MEAN |
| PRIMARY | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6) | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint. | mmHg | MEAN |
| SECONDARY | Number of Participants Who Experience at Least One Adverse Drug Reactions | Up to Month 3 | Safety analysis set was defined as all participants who were enrolled and completed the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14 | Baseline and Last dose of ARB Combination Drug (up to Month 6) | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. | mmHg | MEAN |
| PRIMARY | Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14 | Baseline and Last dose of ARB Combination Drug (up to Month 6) | Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Clinic Blood Pressure in the Sitting Position | Candesartan Cilexetil 4 mg to 8 mg | Month 3, SBP | -20.1 | Standard Deviation 19.30 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position | Candesartan Cilexetil 4 mg to 8 mg | Last Dose of Candesartan, SBP | -18.1 | Standard Deviation 18.91 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position | Candesartan Cilexetil 4 mg to 8 mg | Month 3, DBP | -10.4 | Standard Deviation 12.34 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position | Candesartan Cilexetil 4 mg to 8 mg | Last Dose of Candesartan, DBP | -9.3 | Standard Deviation 12.12 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Candesartan Cilexetil 4 mg to 8 mg | Month 3, SBP | -19.8 | Standard Deviation 18.74 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Candesartan Cilexetil 4 mg to 8 mg | Last Dose of Candesartan, SBP | -19.5 | Standard Deviation 18.64 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Candesartan Cilexetil 4 mg to 8 mg | Month 3, DBP | -10.1 | Standard Deviation 12.01 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14 | Candesartan Cilexetil 4 mg to 8 mg | Last Dose of Candesartan, DBP | -10.0 | Standard Deviation 12.03 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Candesartan Cilexetil 4 mg to 8 mg | Month 3, SBP | -21.7 | Standard Deviation 20.74 | mmHg |
| Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14 | Candesartan Cilexetil 4 mg to 8 mg | Last Dose of Candesartan, SBP | -12.3 | Standard Deviation 18.83 | mmHg |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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 4 mg to 8 mg | 18,113 | |
| Overall Study | COMPLETED | Candesartan Cilexetil 4 mg to 8 mg | 17,130 | |
| Overall Study | NOT COMPLETED | Candesartan Cilexetil 4 mg to 8 mg | 983 |
Source ClinicalTrials.gov
Adverse events40
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 | Dizziness | Nervous system disorders | Candesartan Cilexetil 4 mg to 8 mg | 41 | 17,130 | |
| serious | Pneumonia | Infections and infestations | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Papillary tumour of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 | |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Candesartan Cilexetil 4 mg to 8 mg | 1 | 17,130 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Candesartan Cilexetil 4 mg to 8 mg | ||
| Total, other adverse events | Candesartan Cilexetil 4 mg to 8 mg | 41 | 17,130 |
| Total, serious adverse events | Candesartan Cilexetil 4 mg to 8 mg | 36 | 17,130 |
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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