HypertensionPhase 3NCT00434967
Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
A Phase 3 study testing Candesartan cilexetil, Hydrochlorothiazide and Candesartan/HCT 32/25 mg in people with Hypertension, run by AstraZeneca at 27 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan cilexetil, Hydrochlorothiazide and Candesartan/HCT 32/25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,207 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
- Provision of signed Informed Consent
- Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.
- Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2
- Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
- Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the 4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 weeks.
Who cannot join
- Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1.
- Secondary or malignant hypertension
- Sitting SBP of 180 mmHg or more
- Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
- Angina pectoris requiring more treatment than short-acting nitrates
- Chronic use of NSAIDs
Show all 18Show fewer
- Aortic or mitral valve stenosis
- Cardiac failure requiring treatment
- Cardiac arrhythmia requiring treatment
- Gout
- Renal artery stenosis or kidney transplantation
- Intravascular volume depletion
- Hypersensitivity to any component of the investigational products or to any sulphonamide derived drugs
- Concomitant disease which may interfere with the assessment of the patient
- Past or present alcohol or drug abuse, or any condition associated with poor compliance that in the opinion of the investigator might affect the patient's participation in the study
- Chronic liver disease
- Concomitant or previous treatment with any other investigational drug within 20 days of enrolment
- Previous enrolment in the present study
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Belgium8 sites
Research Site
Dour
Research Site
Gozée
Research Site
Hasselt
Research Site
Linkebeek
Research Site
Marchovelette
Research Site
Ronquières
Research Site
Saint-Médard
Research Site
Steenokkerzel
Romania7 sites
Research Site
Arad
Research Site
Bucharest
Research Site
Iași
Research Site
Piteşti
Research Site
Ploieşti
Research Site
Targoviste
Research Site
Timișoara
Slovakia5 sites
Research Site
Bratislava
Research Site
Levice
Research Site
Lučenec
Research Site
Prešov
Research Site
Šahy
About this study
Official title: A Double-blind, Randomised, 4-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults
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.
- Conditions
- Hypertension
- Being tested
- Candesartan cilexetil, Hydrochlorothiazide, Candesartan/HCT 32/25 mg
- Keywords
- Blood pressure reduction, combination therapy, candesartan cilexetil, hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan cilexetilDrug
Also called ATACAND
32 mg oral tablet
HydrochlorothiazideDrug
Also called HCTZ
25 mg oral tablet
Candesartan/HCT 32/25 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 4 | No intervention | Placebo |
| 2 | Active comparator | Candesartan cilexetil Receives: Drug: Candesartan cilexetil |
| 3 | Active comparator | Hydrochlorothiazide (HCT) Receives: Drug: Hydrochlorothiazide |
| 1 | Experimental | Candesartan cilexetil + Hydrochlorothiazide Combination Receives: Drug: Candesartan cilexetil; Drug: Hydrochlorothiazide; Drug: Candesartan/HCT 32/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (6)
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Klibaner, MD, Study director, AstraZenecaIstvan Edes, MD, Principal investigator, DEOEC Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434967
- Sponsor's protocol ID
- D2456C00002
- Other IDs
- EudraCT No. 2006-003963-30
- Status last verified
- Nov 2010
- First submitted
- 13 Feb 2007
- Last updated
- 16 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, 4-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults
- ClinicalTrials.gov ID
- NCT00434967
- Acronym / sponsor ID
- D2456C00002
- Conditions
- Hypertension
- Keywords
- Blood pressure reduction, combination therapy, candesartan cilexetil, hydrochlorothiazide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,207 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Feb 2007 (estimated)
- Results
- Posted 17 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 | No intervention | –Placebo |
| 2 | Active comparator | Drug: Candesartan cilexetilCandesartan cilexetil |
| 3 | Active comparator | Drug: HydrochlorothiazideHydrochlorothiazide (HCT) |
| 1 | Experimental | Drug: Candesartan cilexetil, Drug: Hydrochlorothiazide, Drug: Candesartan/HCT 32/25 mgCandesartan cilexetil + Hydrochlorothiazide Combination |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
- Provision of signed Informed Consent
- Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.
- Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2
- Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
Key exclusion criteria (18 listed)
- Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1.
- Secondary or malignant hypertension
- Sitting SBP of 180 mmHg or more
- Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
- Angina pectoris requiring more treatment than short-acting nitrates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candesartan cilexetilAlso: ATACAND32 mg oral tablet | Drug | 1, 2 |
| HydrochlorothiazideAlso: HCTZ25 mg oral tablet | Drug | 1, 3 |
| Candesartan/HCT 32/25 mg | Drug | 1 |
Primary outcome
Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).
Time frame: 8 weeks
Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)
Time frame: 8 weeks
Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.
6 secondary outcomes
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
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
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
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
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
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Klibaner, MD study director
AstraZeneca
Istvan Edes, MD principal investigator
DEOEC Institute of Cardiology
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan cilexetil, Hydrochlorothiazide and Candesartan/HCT 32/25 mg in people with Hypertension, run by AstraZeneca at 27 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Belgium, Romania, Slovakia, Latvia, Malta and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010.