Stage II HypertensionPhase 4CAESARNCT00621153
Candesartan Effect in Second Stage Arterial Hypertension
A Phase 4 study testing Candesartan Cilexetil and Hydrochlorothiazide in people with Stage II Hypertension, run by AstraZeneca at 1 site in South Korea.
Trial summary
To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage II Hypertension
- What is being tested?
- Candesartan Cilexetil and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Mar 2009
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs
Who cannot join
- Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.
- Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomised, 2-Arm Parallel Group, Multicentre, 8-week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults
To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
- Conditions
- Stage II Hypertension
- Being tested
- Candesartan Cilexetil, Hydrochlorothiazide
- Keywords
- Candesartan Cilexetil, hydrochlorothiazide, severe hypertension
- 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
Candesartan Cilexetil 16 mg oral
HydrochlorothiazideDrug
Also called HCTZ, Diazide
Hydrochlorothiazide 12.5 mg
Candesartan CilexetilDrug
Also called Atacand
Candesartan Cilexetil 32 mg oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Candesartan cilexetil 16mg monotherapy Receives: Drug: Candesartan Cilexetil |
| 2 | Experimental | Candesartan cilexetil 16mg/HCT combination therapy Receives: Drug: Candesartan Cilexetil; Drug: Hydrochlorothiazide |
| 3 | Active comparator | candesartan cilexetil 32mg monotherapy Receives: Drug: Candesartan Cilexetil |
| 4 | Experimental | Candesartan Cilexetil 32 mg/HCT combination therapy Receives: Drug: Hydrochlorothiazide; Drug: Candesartan Cilexetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
Mean of the changed DBP from baseline after 4 weeks
Measured: 4 weeks
Secondary outcomes (7)
Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
Mean of the changed SBP from baseline after 4 weeks
Measured: 4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy
Percent of the patients achieving goal DBP and SBP after 4 weeks
Measured: 4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy
Percent of patients achieving goal of DBP
Measured: 8 weeks
Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
Changed SBP from baseline after 8 weeks
Measured: 8 weeks
Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
Change of hs-CRP from basline after 8 weeks
Measured: 8 weeks
Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)
Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks
Measured: 8 weeks
Compliance Levels at 4 Weeks and 8 Weeks of Therapy
Percent of the number of returened pills to the number of prescrited pills
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage II 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dong Hoon Choi, Principal investigator, Severance HospitalJoonwoo Bahn, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621153
- Sponsor's protocol ID
- D2452L00016
- Acronym
- CAESAR
- Status last verified
- Apr 2009
- First submitted
- 24 Jan 2008
- Last updated
- 23 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee HY, Hong BK, Chung WJ, Lee BK, Lee SH, Jeon DW, Ahn YK, Kim D, Park CK, Kim SH, Jung HO, Kim BO, Choi D. Phase IV, 8-week, multicenter, randomized, active treatment-controlled, parallel group, efficacy, and tolerability study of high-dose candesartan cilexetil combined with hydrochlorothiazide in Korean adults with stage II hypertension. Clin Ther. 2011 Aug;33(8):1043-56. doi: 10.1016/j.clinthera.2011.07.002. Epub 2011 Aug 10.
PubMed 21831438
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomised, 2-Arm Parallel Group, Multicentre, 8-week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults
- ClinicalTrials.gov ID
- NCT00621153
- Acronym / sponsor ID
- CAESAR / D2452L00016
- Conditions
- Stage II Hypertension
- Keywords
- Candesartan Cilexetil, hydrochlorothiazide, severe hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 23 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Candesartan CilexetilCandesartan cilexetil 16mg monotherapy |
| 2 | Experimental | Drug: Candesartan Cilexetil, Drug: HydrochlorothiazideCandesartan cilexetil 16mg/HCT combination therapy |
| 3 | Active comparator | Drug: Candesartan Cilexetilcandesartan cilexetil 32mg monotherapy |
| 4 | Experimental | Drug: Hydrochlorothiazide, Drug: Candesartan CilexetilCandesartan Cilexetil 32 mg/HCT combination therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs
Key exclusion criteria (2 listed)
- Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.
- Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
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: AtacandCandesartan Cilexetil 16 mg oral | Drug | 1, 2 |
| HydrochlorothiazideAlso: HCTZ, DiazideHydrochlorothiazide 12.5 mg | Drug | 2, 4 |
| Candesartan CilexetilAlso: AtacandCandesartan Cilexetil 32 mg oral | Drug | 3, 4 |
Primary outcome
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
Time frame: 4 weeks
Mean of the changed DBP from baseline after 4 weeks
7 secondary outcomes
Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
Time frame: 4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy
Time frame: 4 weeks
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy
Time frame: 8 weeks
Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
Time frame: 8 weeks
Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
Time frame: 8 weeks
Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)
Time frame: 8 weeks
Compliance Levels at 4 Weeks and 8 Weeks of Therapy
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21831438Lee HY, Hong BK, Chung WJ, Lee BK, Lee SH, Jeon DW, Ahn YK, Kim D, Park CK, Kim SH, Jung HO, Kim BO, Choi D. Phase IV, 8-week, multicenter, randomized, active treatment-controlled, parallel group, efficacy, and tolerability study of high-dose candesartan cilexetil combined with hydrochlorothiazide in Korean adults with stage II hypertension. Clin Ther. 2011 Aug;33(8):1043-56. doi: 10.1016/j.clinthera.2011.07.002. Epub 2011 Aug 10.
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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.
Dong Hoon Choi principal investigator
Severance Hospital
Joonwoo Bahn study director
AstraZeneca Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan Cilexetil and Hydrochlorothiazide in people with Stage II Hypertension, run by AstraZeneca at 1 site in South Korea.
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 1 inclusion and 2 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 23 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Mar 2010). 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?
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621153, which also lists 1 linked publication.
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 23 Mar 2010.