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

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: NCT00434967
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : June 17, 2009
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Candesartan cilexetil
Drug: Hydrochlorothiazide
Drug: Candesartan/HCT 32/25 mg
Enrollment 2207
Recruitment Details 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 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.
Arm/Group Title Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Hide Arm/Group Description 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 (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 (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 (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)
Period Title: Overall Study
Started 97 465 470 492
Completed 90 457 461 478
Not Completed 7 8 9 14
Reason Not Completed
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
Arm/Group Title Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg Total
Hide Arm/Group Description 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 (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 (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 (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 of all reporting groups
Overall Number of Baseline Participants 92 457 464 486 1499
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 92 participants 457 participants 464 participants 486 participants 1499 participants
52.7
(28 to 76)
51.7
(21 to 79)
50.9
(21 to 78)
52.7
(22 to 77)
52
(21 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 457 participants 464 participants 486 participants 1499 participants
Female
51
  55.4%
255
  55.8%
273
  58.8%
285
  58.6%
864
  57.6%
Male
41
  44.6%
202
  44.2%
191
  41.2%
201
  41.4%
635
  42.4%
1.Primary Outcome
Title Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).
Hide Description Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Hide Arm/Group Description:
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 (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 (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 (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)
Overall Number of Participants Analyzed 89 431 441 464
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-3.3  (0.9) -9.3  (0.4) -7.7  (0.4) -13.9  (0.4)
2.Primary Outcome
Title Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)
Hide Description Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Hide Arm/Group Description:
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 (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 (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 (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)
Overall Number of Participants Analyzed 89 431 441 464
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-3.7  (1.5) -13.1  (0.7) -11.6  (0.7) -21.4  (0.6)
3.Secondary Outcome
Title The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study
Hide Description Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Hide Arm/Group Description:
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 (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 (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 (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)
Overall Number of Participants Analyzed 89 431 441 464
Measure Type: Number
Unit of Measure: participants
8 198 168 304
4.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame Baseline to 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline to 8 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline to 8 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame Baseline to 8 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame Baseline to 8 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Hide Arm/Group Description 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 (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 (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 (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)
All-Cause Mortality
Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2   6   2   1 
Cardiac disorders         
Acute Coronary Syndrome † 1  0/97 (0.00%)  0/465 (0.00%)  1/470 (0.21%)  0/492 (0.00%) 
Cardiac Failure † 1  1/97 (1.03%)  0/465 (0.00%)  0/470 (0.00%)  0/492 (0.00%) 
Hypotension † 1  0/97 (0.00%)  0/465 (0.00%)  0/470 (0.00%)  1/492 (0.20%) 
Infections and infestations         
Pneumonia † 1  0/97 (0.00%)  1/465 (0.22%)  0/470 (0.00%)  0/492 (0.00%) 
Sudden Death † 1  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  0/97 (0.00%)  1/465 (0.22%)  0/470 (0.00%)  0/492 (0.00%) 
Investigations         
Electrocardiogram Abnormal † 1  1/97 (1.03%)  0/465 (0.00%)  0/470 (0.00%)  0/492 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back Pain † 1  0/97 (0.00%)  1/465 (0.22%)  0/470 (0.00%)  0/492 (0.00%) 
Nervous system disorders         
Cerebrovascular Accident † 1  0/97 (0.00%)  1/465 (0.22%)  0/470 (0.00%)  0/492 (0.00%) 
Psychiatric disorders         
Major Depression † 1  0/97 (0.00%)  1/465 (0.22%)  1/470 (0.21%)  0/492 (0.00%) 
†
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 2%
Placebo Candesartan 32 mg HCT 25 mg Candesartan/HCT 32/25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0   38   22   23 
Cardiac disorders         
Hypertension † 1  0/97 (0.00%)  10/465 (2.15%)  0/470 (0.00%)  0/492 (0.00%) 
Infections and infestations         
Influenza † 1  0/97 (0.00%)  10/465 (2.15%)  0/470 (0.00%)  0/492 (0.00%) 
Nervous system disorders         
Dizziness † 1  0/97 (0.00%)  0/465 (0.00%)  0/470 (0.00%)  13/492 (2.64%) 
Headache † 1  0/97 (0.00%)  18/465 (3.87%)  22/470 (4.68%)  10/492 (2.03%) 
†
Indicates events were collected by systematic assessment
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.
AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed in order for AstraZeneca to file patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: AZTrial_Results_Posting@astrazeneca.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00434967    
Other Study ID Numbers: D2456C00002
EudraCT No. 2006-003963-30
First Submitted: February 13, 2007
First Posted: February 14, 2007
Results First Submitted: January 9, 2009
Results First Posted: June 17, 2009
Last Update Posted: December 16, 2010