Trial · NCT01762501
Azilsartan Circadian and Sleep Pressure
NCT01762501, Not applicable, Completed, Sogo Rinsho Médéfi Co., Ltd.; results first posted 2015-12-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Azilsartan Circadian and Sleep Pressure. Trials, record NCT01762501. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01762501
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Azilsartan Circadian and Sleep Pressure
- NCT number
- NCT01762501
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 957 participants, actual
- Lead sponsor
- Sogo Rinsho Médéfi Co., Ltd.
- Conditions
- Hypertension
- Interventions
- Azilsartan, Amlodipine
- First posted
- 2013-01-07
- Last updated
- 2015-12-28
- Results first posted
- 2015-12-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Nocturnal Systolic Blood Pressure Level | Baseline and 8 weeks | Change at the end of a treatment period (Week 8) from the beginning point of an observation period \*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping) |
| Secondary | Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Baseline and 8 weeks | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) \*The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent) \*\* Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP |
| Secondary | Change in Nocturnal Diastolic Blood Pressure Level | Baseline and 8 weeks | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) |
| Secondary | Change in 24-hour Mean Systolic Blood Pressure Level | Baseline and 8 weeks | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) |
| Secondary | Change in 24-hour Mean Diastolic Blood Pressure Level | Baseline and 8 weeks | Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Nocturnal Systolic Blood Pressure Level | Baseline and 8 weeks | mmHg | MEAN | |
| SECONDARY | Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Baseline and 8 weeks | mmHg | MEAN | |
| SECONDARY | Change in Nocturnal Diastolic Blood Pressure Level | Baseline and 8 weeks | mmHg | MEAN | |
| SECONDARY | Change in 24-hour Mean Systolic Blood Pressure Level | Baseline and 8 weeks | mmHg | MEAN | |
| SECONDARY | Change in 24-hour Mean Diastolic Blood Pressure Level | Baseline and 8 weeks | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Nocturnal Systolic Blood Pressure Level | Azilsartan | -12.6 | Standard Deviation 15.4 | mmHg | |
| Change in Nocturnal Systolic Blood Pressure Level | Amlodipine | -17.5 | Standard Deviation 14.0 | mmHg | |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Azilsartan | riser | -7.3 | 95% Confidence Interval -10.0 to -4.5 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Amlodipine | riser | -10.1 | 95% Confidence Interval -13.5 to -6.6 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Azilsartan | non-dipper | -0.7 | 95% Confidence Interval -1.9 to 0.6 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Amlodipine | non-dipper | -2.1 | 95% Confidence Interval -3.1 to -1.1 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Azilsartan | dipper | 4.5 | 95% Confidence Interval 3.6 to 5.4 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Amlodipine | dipper | 3.1 | 95% Confidence Interval 2.3 to 3.8 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Azilsartan | extreme dipper | -1.9 | 95% Confidence Interval -3.9 to 0.1 | mmHg |
| Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall** | Amlodipine | extreme dipper | -3.1 | 95% Confidence Interval -4.9 to -1.2 | mmHg |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azilsartan | 359 | |
| Overall Study | STARTED | Amlodipine | 359 | |
| Overall Study | COMPLETED | Azilsartan | 332 | |
| Overall Study | COMPLETED | Amlodipine | 336 | |
| Overall Study | NOT COMPLETED | Azilsartan | 27 | |
| Overall Study | NOT COMPLETED | Amlodipine | 23 |
Source ClinicalTrials.gov
Adverse events12
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 | Infectious disease | Infections and infestations | Azilsartan | 30 | 359 | |
| other | Infectious disease | Infections and infestations | Amlodipine | 34 | 359 | |
| other | Other | Musculoskeletal and connective tissue disorders | Azilsartan | 62 | 359 | |
| other | Other | Musculoskeletal and connective tissue disorders | Amlodipine | 49 | 359 | |
| serious | Diverticulitis | Gastrointestinal disorders | Azilsartan | 0 | 359 | |
| serious | Diverticulitis | Gastrointestinal disorders | Amlodipine | 1 | 359 | |
| serious | Stroke | Vascular disorders | Azilsartan | 0 | 359 | |
| serious | Stroke | Vascular disorders | Amlodipine | 1 | 359 | |
| serious | Nettle rash | Skin and subcutaneous tissue disorders | Azilsartan | 0 | 359 | |
| serious | Nettle rash | Skin and subcutaneous tissue disorders | Amlodipine | 1 | 359 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azilsartan | ||
| Total, all-cause mortality | Amlodipine | ||
| Total, other adverse events | Azilsartan | 91 | 359 |
| Total, other adverse events | Amlodipine | 77 | 359 |
| Total, serious adverse events | Azilsartan | 0 | 359 |
| Total, serious adverse events | Amlodipine | 5 | 359 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25646296 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Azilsartan vs Amlodipine: serious adverse events |
Source Trial comparisons
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/NCT01762501
GET https://conductscience.org/api/trials/v1/NCT01762501/registered