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Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621153
First Posted: February 22, 2008
Last Update Posted: March 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
Results First Submitted: February 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  

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

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

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 reported.   Anticipated Reporting Date:   No text entered.  

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


  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 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.


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


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

ClinicalTrials.gov Identifier: NCT00621153     History of Changes
Other Study ID Numbers: D2452L00016
First Submitted: January 24, 2008
First Posted: February 22, 2008
Results First Submitted: February 24, 2010
Results First Posted: March 23, 2010
Last Update Posted: March 23, 2010