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Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00621153
First received: January 24, 2008
Last updated: February 24, 2010
Last verified: April 2009

January 24, 2008
February 24, 2010
February 2008
March 2009   (final data collection date for primary outcome measure)
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean of the changed DBP from baseline after 4 weeks
changes in mean sitting DBP [ Time Frame: 4 weeks from therapy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00621153 on ClinicalTrials.gov Archive Site
  • Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent of patients achieving goal of DBP
  • Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Changed SBP from baseline after 8 weeks
  • Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percent of the number of returened pills to the number of prescrited pills
mean sitting SBP from baseline [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Candesartan Effect in Second Stage Arterial Hypertension
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage II Hypertension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00621153
D2452L00016
No
Not Provided
AstraZeneca
Not Provided
Principal Investigator: Dong Hoon Choi Severance Hospital
Study Director: Joonwoo Bahn AstraZeneca Korea
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP