Trial · NCT02016183
Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
NCT02016183, Completed, Takeda; results first posted 2018-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months). Trials, record NCT02016183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02016183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
- NCT number
- NCT02016183
- Status
- Completed
- Enrollment
- 3,222 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hypertension
- Interventions
- Candesartan cilexetil / hydrochlorothiazide
- First posted
- 2013-12-19
- Last updated
- 2018-11-09
- Results first posted
- 2018-11-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 12 months | ADRs 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. |
| Secondary | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) | Reported data are changes in SBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment. |
| Secondary | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) | Reported data are changes in DBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment. |
| Secondary | Changes From Baseline in Pulse Rate at Each Time Point | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) | Reported data are changes in Pulse Rate from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Up to 12 months | The safety analysis set was defined as all participants who were enrolled and completed the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point. | mmHg | MEAN |
| SECONDARY | Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point. | mmHg | MEAN |
| SECONDARY | Changes From Baseline in Pulse Rate at Each Time Point | Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months) | The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point. | Beats per minutes | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | Candesartan Cilexetil/Hydrochlorothiazide | 283 | Participants | ||
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 1 | -13.3 | Standard Deviation 18.02 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 2 | -14.8 | Standard Deviation 18.48 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 3 | -15.4 | Standard Deviation 19.06 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 4 | -15.7 | Standard Deviation 19.34 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 5 | -15.6 | Standard Deviation 19.17 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 6 | -16.1 | Standard Deviation 18.94 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 7 | -15.8 | Standard Deviation 19.27 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 8 | -15.8 | Standard Deviation 19.12 | mmHg |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point | Candesartan Cilexetil/Hydrochlorothiazide | Change in SBP at Month 9 | -16.4 | Standard Deviation 18.86 | mmHg |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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/Hydrochlorothiazide | 3,222 | |
| Overall Study | COMPLETED | Candesartan Cilexetil/Hydrochlorothiazide | 3,157 | |
| Overall Study | NOT COMPLETED | Candesartan Cilexetil/Hydrochlorothiazide | 65 |
Source ClinicalTrials.gov
Adverse events71
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 | Hyperuricaemia | Metabolism and nutrition disorders | Candesartan Cilexetil/Hydrochlorothiazide | 81 | 3,157 | |
| other | Blood uric acid increased | Investigations | Candesartan Cilexetil/Hydrochlorothiazide | 77 | 3,157 | |
| serious | Bronchopneumonia | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 | |
| serious | Pharyngitis | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 | |
| serious | Pneumonia | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 5 | 3,157 | |
| serious | Pyelonephritis acute | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 | |
| serious | Urinary tract infection | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 | |
| serious | Pneumonia bacterial | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 | |
| serious | Atypical mycobacterial infection | Infections and infestations | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 | |
| serious | Acute monocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Candesartan Cilexetil/Hydrochlorothiazide | 1 | 3,157 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Candesartan Cilexetil/Hydrochlorothiazide | ||
| Total, other adverse events | Candesartan Cilexetil/Hydrochlorothiazide | 158 | 3,157 |
| Total, serious adverse events | Candesartan Cilexetil/Hydrochlorothiazide | 72 | 3,157 |
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/NCT02016183
GET https://conductscience.org/api/trials/v1/NCT02016183/results?page=2