Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Azilsartan Circadian and Sleep Pressure

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sogo Rinsho Médéfi Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01762501
First received: December 18, 2012
Last updated: November 19, 2015
Last verified: November 2015
Results First Received: November 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Azilsartan
Drug: Amlodipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment was performed at hospital and clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
957 patients was enrolled in this study. In run-in period, 239 patients were withdrawn.

Reporting Groups
  Description
Azilsartan

Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks

Azilsartan: Azilsartan 20mg/day

Amlodipine

Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks

Amlodipine: Amlodipine 5mg/day


Participant Flow:   Overall Study
    Azilsartan     Amlodipine  
STARTED     359     359  
COMPLETED     332     336  
NOT COMPLETED     27     23  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azilsartan

Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks

Azilsartan: Azilsartan 20mg/day

Amlodipine

Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks

Amlodipine: Amlodipine 5mg/day

Total Total of all reporting groups

Baseline Measures
    Azilsartan     Amlodipine     Total  
Number of Participants  
[units: participants]
  359     359     718  
Age  
[units: years]
Mean (Standard Deviation)
  61  (12)     61  (12)     61  (12)  
Gender  
[units: participants]
     
Female     157     157     314  
Male     202     202     404  
Region of Enrollment  
[units: participants]
     
Japan     359     359     718  
Clinic SBP  
[units: mmHg]
Mean (Standard Deviation)
  149.6  (10.2)     150.5  (10.2)     150.1  (10.2)  
Clinic DBP  
[units: mmHg]
Mean (Standard Deviation)
  90.3  (9.4)     89.8  (9.6)     90.1  (9.5)  
24-hour SBP  
[units: mmHg]
Mean (Standard Deviation)
  150.6  (13.0)     152.4  (13.7)     151.5  (13.4)  
24-hour DBP  
[units: mmHg]
Mean (Standard Deviation)
  89.3  (8.6)     90.4  (9.3)     89.8  (9.0)  



  Outcome Measures
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1.  Primary:   Change in Nocturnal Systolic Blood Pressure Level   [ Time Frame: Baseline and 8 weeks ]

2.  Secondary:   Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Change in Nocturnal Diastolic Blood Pressure Level   [ Time Frame: Baseline and 8 weeks ]

4.  Secondary:   Change in 24-hour Mean Systolic Blood Pressure Level   [ Time Frame: Baseline and 8 weeks ]

5.  Secondary:   Change in 24-hour Mean Diastolic Blood Pressure Level   [ Time Frame: Baseline and 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Naoyuki Takano
Organization: Sogo Rinsho Medefi Co., Ltd
phone: +81-3-6901-6079
e-mail: takano.naoyuki@sogo-medefi.jp


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sogo Rinsho Médéfi Co., Ltd.
ClinicalTrials.gov Identifier: NCT01762501     History of Changes
Other Study ID Numbers: ACS1
Study First Received: December 18, 2012
Results First Received: November 19, 2015
Last Updated: November 19, 2015
Health Authority: Japan: Institutional Review Board