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
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