We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by:
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Stage II Hypertension Drug: Candesartan Cilexetil Drug: Hydrochlorothiazide Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy [ Time Frame: 8 weeks ]
    Changed SBP from baseline after 8 weeks

  5. 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

  6. 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

  7. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621153


Locations
Layout table for location information
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Dong Hoon Choi Severance Hospital
Study Director: Joonwoo Bahn AstraZeneca Korea
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00621153    
Other Study ID Numbers: D2452L00016
First Posted: February 22, 2008    Key Record Dates
Results First Posted: March 23, 2010
Last Update Posted: March 23, 2010
Last Verified: April 2009
Keywords provided by AstraZeneca:
Candesartan Cilexetil
hydrochlorothiazide
severe hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists