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
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