Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

• ClinicalTrials.gov Identifier: NCT00621153
• Recruitment Status: Completed
• First Posted: February 22, 2008
• Results First Posted: March 23, 2010
• Last Update Posted: March 23, 2010
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: January 24, 2008
• First Posted Date: February 22, 2008
• Results First Submitted Date: February 24, 2010
• Results First Posted Date: March 23, 2010
• Last Update Posted Date: March 23, 2010
• Study Start Date: February 2008
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2010)

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

• Original Primary Outcome Measures (submitted: February 12, 2008): changes in mean sitting DBP [ Time Frame: 4 weeks from therapy ]

Current Secondary Outcome Measures (submitted: February 24, 2010)

• Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy [ Time Frame: 4 weeks ]
  Mean of the changed SBP from baseline after 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 ]
  Percent of the patients achieving goal DBP and SBP after 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 ]
  Percent of patients achieving goal of DBP
• Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ]
  Changed SBP from baseline after 8 weeks
• Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ]
  Change of hs-CRP from basline after 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 ]
  Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks
• Compliance Levels at 4 Weeks and 8 Weeks of Therapy [ Time Frame: 8 weeks ]
  Percent of the number of returened pills to the number of prescrited pills

• Original Secondary Outcome Measures (submitted: February 12, 2008): mean sitting SBP from baseline [ Time Frame: after 4 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stage II Hypertension

Intervention

• Drug: Candesartan Cilexetil
  Candesartan Cilexetil 16 mg oral
  Other Name: Atacand
• Drug: Hydrochlorothiazide
  Hydrochlorothiazide 12.5 mg
  Other Names:

  • HCTZ
  • Diazide
• Drug: Candesartan Cilexetil
  Candesartan Cilexetil 32 mg oral
  Other Name: Atacand

Study Arms

• Active Comparator: 1
  Candesartan cilexetil 16mg monotherapy
  Intervention: Drug: Candesartan Cilexetil
• Experimental: 2
  Candesartan cilexetil 16mg/HCT combination therapy
  Interventions:

  • Drug: Candesartan Cilexetil
  • Drug: Hydrochlorothiazide
• Active Comparator: 3
  candesartan cilexetil 32mg monotherapy
  Intervention: Drug: Candesartan Cilexetil
• Experimental: 4
  Candesartan Cilexetil 32 mg/HCT combination therapy
  Interventions:

  • Drug: Hydrochlorothiazide
  • Drug: Candesartan Cilexetil

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 24, 2009): 214
• Original Estimated Enrollment (submitted: February 12, 2008): 160
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT00621153
• Other Study ID Numbers: D2452L00016
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: AstraZeneca
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dong Hoon Choi; Severance Hospital
• Study Director: Joonwoo Bahn; AstraZeneca Korea

• PRS Account: AstraZeneca
• Verification Date: April 2009