Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00621153
First received: January 24, 2008
Last updated: February 24, 2010
Last verified: April 2009
Results First Received: February 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stage II Hypertension
Interventions: Drug: Candesartan Cilexetil
Drug: Hydrochlorothiazide

  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
253 enrolled, 20 screening failure, 223 randomised, 198 completed

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy
Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy

Participant Flow:   Overall Study
    Candesartan Cilexetil/Hydroclorozide Combination Therapy     Candesartan Cilexetil Monotherapy  
STARTED     117 [1]   116 [1]
Discontinued     20     15  
COMPLETED     97 [2]   101 [2]
NOT COMPLETED     20     15  
Safety Reason                 8                 7  
Adverse Event                 3                 2  
Lost to Follow-up                 5                 1  
Withdrawal by Subject                 4                 5  
[1] randomised
[2] completed



  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
Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy
Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy
Total Total of all reporting groups

Baseline Measures
    Candesartan Cilexetil/Hydroclorozide Combination Therapy     Candesartan Cilexetil Monotherapy     Total  
Number of Participants  
[units: participants]
  117     116     233  
Age  
[units: years]
Mean ± Standard Deviation
  51.00  ± 10     47.80  ± 10     48.90  ± 10  
Gender  
[units: Participants]
     
Female     42     38     80  
Male     75     78     153  



  Outcome Measures

1.  Primary:   Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy   [ Time Frame: 4 weeks ]

2.  Secondary:   Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy   [ Time Frame: 4 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy   [ Time Frame: 4 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE’s From Baseline (Randomisation) to the End of the Study (8 Weeks)   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Compliance Levels at 4 Weeks and 8 Weeks of Therapy   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: +44 1509 64589 ext 4589
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


ClinicalTrials.gov Identifier: NCT00621153     History of Changes
Other Study ID Numbers: D2452L00016
Study First Received: January 24, 2008
Results First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: Korea: Food and Drug Administration