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Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

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.
 
ClinicalTrials.gov Identifier: NCT00621153
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : March 23, 2010
Last Update Posted : March 23, 2010
Sponsor:
Information provided by:
AstraZeneca

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
Enrollment 214
Recruitment Details 253 enrolled, 20 screening failure, 223 randomised, 198 completed
Pre-assignment Details  
Arm/Group Title Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy
Hide Arm/Group Description candesartan cilexetil/Hydroclorozide combination therapy candesartan cilexetil monotherapy
Period Title: Overall Study
Started 117 [1] 116 [1]
Discontinued 20 15
Completed 97 [2] 101 [2]
Not Completed 20 15
Reason Not Completed
Safety Reason             8             7
Adverse Event             3             2
Lost to Follow-up             5             1
Withdrawal by Subject             4             5
[1]
randomised
[2]
completed
Arm/Group Title Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy Total
Hide Arm/Group Description candesartan cilexetil/Hydroclorozide combination therapy candesartan cilexetil monotherapy Total of all reporting groups
Overall Number of Baseline Participants 117 116 233
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants 116 participants 233 participants
51.00  (10) 47.80  (10) 48.90  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 116 participants 233 participants
Female
42
  35.9%
38
  32.8%
80
  34.3%
Male
75
  64.1%
78
  67.2%
153
  65.7%
1.Primary Outcome
Title Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
Hide Description Mean of the changed DBP from baseline after 4 weeks
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy
Hide Arm/Group Description:
candesartan cilexetil/Hydroclorozide combination therapy
candesartan cilexetil monotherapy
Overall Number of Participants Analyzed 111 113
Least Squares Mean (Standard Deviation)
Unit of Measure: mmHg
-17.0  (0.89) -14.1  (0.88)
2.Secondary Outcome
Title Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
Hide Description Mean of the changed SBP from baseline after 4 weeks
Time Frame 4 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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
Hide Description Percent of the patients achieving goal DBP and SBP after 4 weeks
Time Frame 4 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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
Hide Description Percent of patients achieving goal of DBP
Time Frame 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
Hide Description Changed SBP from baseline after 8 weeks
Time Frame 8 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
Hide Description Change of hs-CRP from basline after 8 weeks
Time Frame 8 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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)
Hide Description Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks
Time Frame 8 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Compliance Levels at 4 Weeks and 8 Weeks of Therapy
Hide Description Percent of the number of returened pills to the number of prescrited pills
Time Frame 8 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy
Hide Arm/Group Description candesartan cilexetil/Hydroclorozide combination therapy candesartan cilexetil monotherapy
All-Cause Mortality
Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1   2 
Gastrointestinal disorders     
Anal fistula † 1  1/111 (0.90%)  0/113 (0.00%) 
Renal and urinary disorders     
Breast clacifications † 1  0/111 (0.00%)  1/113 (0.88%) 
Skin and subcutaneous tissue disorders     
Scrub typhus † 1  0/111 (0.00%)  1/113 (0.88%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Candesartan Cilexetil/Hydroclorozide Combination Therapy Candesartan Cilexetil Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   6   3 
Nervous system disorders     
Dizziness 1  6/111 (5.41%)  3/113 (2.65%) 
1
Term from vocabulary, MedDRA 10.0
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
Phone: +44 1509 64589 ext 4589
EMail: aztrial_results_posting@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00621153    
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