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Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00434967
First received: February 13, 2007
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
Results First Received: January 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Candesartan cilexetil
Drug: Hydrochlorothiazide
Drug: Candesartan/HCT 32/25 mg

  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
Following a screening evaluation, patients underwent a 4-week, single-blind treatment with placebo, after which eligible patients were randomly allocated in a 5:5:5:1 ratio to receive 8 weeks of double-blind treatment either with candesartan/Hydrochlorothiazide (HCT) 32/25 mg or candesartan 32 mg or HCT 25 mg or placebo, respectively.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 2207 patients were enrolled in the study at 128 centres in 10 countries, 1772 patients received run in medication and 1524 patients were subsequently randomised to double-blind treatment.

Reporting Groups
  Description
Placebo given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
Candesartan 32 mg candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
HCT 25 mg HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
Candesartan/HCT 32/25 mg candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)

Participant Flow:   Overall Study
    Placebo     Candesartan 32 mg     HCT 25 mg     Candesartan/HCT 32/25 mg  
STARTED     97     465     470     492  
COMPLETED     90     457     461     478  
NOT COMPLETED     7     8     9     14  
Adverse Event                 2                 4                 3                 3  
Lost to Follow-up                 0                 0                 1                 0  
Withdrawal by Subject                 2                 2                 4                 6  
Randomized in error                 0                 0                 0                 1  
Protocol Violation                 0                 1                 0                 1  
Physician Decision                 1                 1                 1                 0  
Patient Disposition Challenges                 2                 0                 0                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
Candesartan 32 mg candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
HCT 25 mg HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
Candesartan/HCT 32/25 mg candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
Total Total of all reporting groups

Baseline Measures
    Placebo     Candesartan 32 mg     HCT 25 mg     Candesartan/HCT 32/25 mg     Total  
Number of Participants  
[units: participants]
 		  92     457     464     486     1499  
Age  
[units: years]
Mean ( Full Range ) 		  52.7  
  ( 28 to 76 )   		  51.7  
  ( 21 to 79 )   		  50.9  
  ( 21 to 78 )   		  52.7  
  ( 22 to 77 )   		  52  
  ( 21 to 79 )  
Gender  
[units: participants]
 		         
Female     51     255     273     285     864  
Male     41     202     191     201     635  



  Outcome Measures
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1.  Primary:   Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).   [ Time Frame: 8 weeks ]
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2.  Primary:   Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)   [ Time Frame: 8 weeks ]
  Show Outcome Measure 2

3.  Secondary:   The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study   [ Time Frame: 8 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).   [ Time Frame: Baseline to 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.   [ Time Frame: Baseline to 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.   [ Time Frame: Baseline to 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).   [ Time Frame: Baseline to 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).   [ Time Frame: Baseline to 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Placebo given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
Candesartan 32 mg candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
HCT 25 mg HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
Candesartan/HCT 32/25 mg candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)

Serious Adverse Events
    Placebo     Candesartan 32 mg     HCT 25 mg     Candesartan/HCT 32/25 mg  
Total, serious adverse events          
# participants affected     2     6     2     1  
Cardiac disorders          
Acute Coronary Syndrome † 1        
# participants affected / at risk     0/97 (0.00%)     0/465 (0.00%)     1/470 (0.21%)     0/492 (0.00%)  
Cardiac Failure † 1        
# participants affected / at risk     1/97 (1.03%)     0/465 (0.00%)     0/470 (0.00%)     0/492 (0.00%)  
Hypotension † 1        
# participants affected / at risk     0/97 (0.00%)     0/465 (0.00%)     0/470 (0.00%)     1/492 (0.20%)  
Infections and infestations          
Pneumonia † 1        
# participants affected / at risk     0/97 (0.00%)     1/465 (0.22%)     0/470 (0.00%)     0/492 (0.00%)  
Sudden Death † 1        
# participants affected / at risk     0/97 (0.00%)     1/465 (0.22%)     0/470 (0.00%)     0/492 (0.00%)  
Injury, poisoning and procedural complications          
Lower Limb Fracture † 1        
# participants affected / at risk     0/97 (0.00%)     1/465 (0.22%)     0/470 (0.00%)     0/492 (0.00%)  
Investigations          
Electrocardiogram Abnormal † 1        
# participants affected / at risk     1/97 (1.03%)     0/465 (0.00%)     0/470 (0.00%)     0/492 (0.00%)  
Musculoskeletal and connective tissue disorders          
Back Pain † 1        
# participants affected / at risk     0/97 (0.00%)     1/465 (0.22%)     0/470 (0.00%)     0/492 (0.00%)  
Nervous system disorders          
Cerebrovascular Accident † 1        
# participants affected / at risk     0/97 (0.00%)     1/465 (0.22%)     0/470 (0.00%)     0/492 (0.00%)  
Psychiatric disorders          
Major Depression † 1        
# participants affected / at risk     0/97 (0.00%)     1/465 (0.22%)     1/470 (0.21%)     0/492 (0.00%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10.0




  Other Adverse Events
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  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.


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
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided


ClinicalTrials.gov Identifier: NCT00434967     History of Changes
Other Study ID Numbers: D2456C00002, EudraCT No. 2006-003963-30
Study First Received: February 13, 2007
Results First Received: January 9, 2009
Last Updated: November 30, 2010
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment