Trial Outcomes & Findings for Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo (NCT NCT00434967)
NCT ID: NCT00434967
Last Updated: 2010-12-16
Results Overview
Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2207 participants
Primary outcome timeframe
8 weeks
Results posted on
2010-12-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
97
|
465
|
470
|
492
|
|
Overall Study
COMPLETED
|
90
|
457
|
461
|
478
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
9
|
14
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
4
|
6
|
|
Overall Study
Randomized in error
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
0
|
|
Overall Study
Patient Disposition Challenges
|
2
|
0
|
0
|
3
|
Baseline Characteristics
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
Baseline characteristics by cohort
| Measure |
Placebo
n=92 Participants
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
n=457 Participants
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
n=464 Participants
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
n=486 Participants
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
n=1499 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
52.7 years
n=93 Participants
|
51.7 years
n=4 Participants
|
50.9 years
n=27 Participants
|
52.7 years
n=483 Participants
|
52 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=93 Participants
|
255 Participants
n=4 Participants
|
273 Participants
n=27 Participants
|
285 Participants
n=483 Participants
|
864 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
202 Participants
n=4 Participants
|
191 Participants
n=27 Participants
|
201 Participants
n=483 Participants
|
635 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 8 weeksChange (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
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
n=431 Participants
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
n=441 Participants
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
n=464 Participants
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)
|
|---|---|---|---|---|
|
Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).
|
-3.3 mm Hg
Standard Error 0.9
|
-9.3 mm Hg
Standard Error 0.4
|
-7.7 mm Hg
Standard Error 0.4
|
-13.9 mm Hg
Standard Error 0.4
|
PRIMARY outcome
Timeframe: 8 weeksChange (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
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
n=431 Participants
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
n=441 Participants
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
n=464 Participants
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)
|
|---|---|---|---|---|
|
Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)
|
-3.7 mm Hg
Standard Error 1.5
|
-13.1 mm Hg
Standard Error 0.7
|
-11.6 mm Hg
Standard Error 0.7
|
-21.4 mm Hg
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 8 weeksControlled sitting SBP and sitting DBP are defined as having sitting SBP \< 140 mmHg and sitting DBP \< 90 mmHg at the end of the study
Outcome measures
| Measure |
Placebo
n=89 Participants
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
n=431 Participants
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
n=441 Participants
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
n=464 Participants
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)
|
|---|---|---|---|---|
|
The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study
|
8 participants
|
198 participants
|
168 participants
|
304 participants
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 8 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 8 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 8 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 8 weeksOutcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Candesartan 32 mg
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
HCT 25 mg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Candesartan/HCT 32/25 mg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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)
|
|---|---|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/97
|
0.00%
0/465
|
0.21%
1/470
|
0.00%
0/492
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/97
|
0.22%
1/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Cardiac disorders
Cardiac Failure
|
1.0%
1/97
|
0.00%
0/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/97
|
0.22%
1/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Investigations
Electrocardiogram Abnormal
|
1.0%
1/97
|
0.00%
0/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Cardiac disorders
Hypotension
|
0.00%
0/97
|
0.00%
0/465
|
0.00%
0/470
|
0.20%
1/492
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/97
|
0.22%
1/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/97
|
0.22%
1/465
|
0.21%
1/470
|
0.00%
0/492
|
|
Infections and infestations
Pneumonia
|
0.00%
0/97
|
0.22%
1/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Infections and infestations
Sudden Death
|
0.00%
0/97
|
0.22%
1/465
|
0.00%
0/470
|
0.00%
0/492
|
Other adverse events
| Measure |
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)
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/97
|
0.00%
0/465
|
0.00%
0/470
|
2.6%
13/492
|
|
Nervous system disorders
Headache
|
0.00%
0/97
|
3.9%
18/465
|
4.7%
22/470
|
2.0%
10/492
|
|
Cardiac disorders
Hypertension
|
0.00%
0/97
|
2.2%
10/465
|
0.00%
0/470
|
0.00%
0/492
|
|
Infections and infestations
Influenza
|
0.00%
0/97
|
2.2%
10/465
|
0.00%
0/470
|
0.00%
0/492
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER