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
  Purpose

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


Condition Intervention Phase
Stage II Hypertension
Drug: Candesartan Cilexetil
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 214
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Candesartan cilexetil 16mg monotherapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
Other Name: Atacand
Experimental: 2
Candesartan cilexetil 16mg/HCT combination therapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
Other Name: Atacand
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg
Other Names:
  • HCTZ
  • Diazide
Active Comparator: 3
candesartan cilexetil 32mg monotherapy
Drug: Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral
Other Name: Atacand
Experimental: 4
Candesartan Cilexetil 32 mg/HCT combination therapy
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg
Other Names:
  • HCTZ
  • Diazide
Drug: Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral
Other Name: Atacand

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621153

Locations
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dong Hoon Choi Severance Hospital
Study Director: Joonwoo Bahn AstraZeneca Korea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00621153     History of Changes
Other Study ID Numbers: D2452L00016
Study First Received: January 24, 2008
Results First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Candesartan Cilexetil
hydrochlorothiazide
severe hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Candesartan
Candesartan cilexetil
Hydrochlorothiazide
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014