Clinical trial NCT00621153: Candesartan Effect in Second Stage Arterial Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stage II Hypertension
Keywords: Candesartan Cilexetil
hydrochlorothiazide
severe hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: 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
timeFrame: 8 weeks
measure: Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
timeFrame: 8 weeks
measure: Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
timeFrame: 8 weeks
measure: 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)
timeFrame: 8 weeks
measure: Compliance Levels at 4 Weeks and 8 Weeks of Therapy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Severance Hospital
name: Dong Hoon Choi
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Korea
name: Joonwoo Bahn
role: STUDY_DIRECTOR
References:
citation: 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.