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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2006-003963-30 |
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The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 | No Intervention | Placebo | |
| 2 | Active Comparator | Candesartan cilexetil |
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| 3 | Active Comparator | Hydrochlorothiazide (HCT) |
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| 1 | Experimental | Candesartan cilexetil + Hydrochlorothiazide Combination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil | Drug | 32 mg oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline. | 8 weeks |
| Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study | 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 | 8 weeks |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Klibaner, MD | AstraZeneca | Study Director |
| Istvan Edes, MD | DEOEC Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Dour | Belgium | ||||
| Research Site |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Candesartan 32 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Hydrochlorothiazide | Drug | 25 mg oral tablet |
|
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| Candesartan/HCT 32/25 mg | Drug |
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| Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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). | Baseline to 8 weeks |
| 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). | Baseline to 8 weeks |
| Gozée |
| Belgium |
| Research Site | Hasselt | Belgium |
| Research Site | Linkebeek | Belgium |
| Research Site | Marchovelette | Belgium |
| Research Site | Ronquières | Belgium |
| Research Site | Saint-Médard | Belgium |
| Research Site | Steenokkerzel | Belgium |
| Research Site | Daugavpils | Latvia |
| Research Site | Ogre | Latvia |
| Research Site | Riga | Latvia |
| Research Site | Gozo | Malta |
| Research Site | Gwardiamangia | Malta |
| Research Site | Arad | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Iași | Romania |
| Research Site | Piteşti | Romania |
| Research Site | Ploieşti | Romania |
| Research Site | Targoviste | Romania |
| Research Site | Timișoara | Romania |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Bratislava | Slovakia |
| Research Site | Levice | Slovakia |
| Research Site | Lučenec | Slovakia |
| Research Site | Prešov | Slovakia |
| Research Site | Šahy | Slovakia |
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) |
| FG002 | 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) |
| FG003 | 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) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). | Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline. | Posted | Least Squares Mean | Standard Error | mm Hg | 8 weeks |
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| Primary | Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) | Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline. | Posted | Least Squares Mean | Standard Error | mm Hg | 8 weeks |
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| Secondary | The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study | 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 | Posted | Number | participants | 8 weeks |
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| 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). | Not Posted | Baseline to 8 weeks | ||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Baseline to 8 weeks | ||||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Baseline to 8 weeks | ||||||||||||||||||||||||||||||||||||||||||
| 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). | Not Posted | Baseline to 8 weeks | ||||||||||||||||||||||||||||||||||||||||||
| 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). | Not Posted | Baseline to 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 2 | 0 | ||||
| EG001 | 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) | 6 | 38 | ||||
| EG002 | 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) | 2 | 22 | ||||
| EG003 | 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) | 1 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Electrocardiogram Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sudden Death | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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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) |
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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) |
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