Candesartan Effect in Second Stage Arterial Hypertension

Stage II Hypertension Clinical Trial

— CAESAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621153
• Other study ID #: D2452L00016
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: February 24, 2010
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Stage II Hypertension

Intervention

Drug:
• Candesartan Cilexetil
Candesartan Cilexetil 16 mg oral
• Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg
• Candesartan Cilexetil
Candesartan Cilexetil 32 mg oral

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy	Mean of the changed DBP from baseline after 4 weeks	4 weeks	No
Secondary	Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy	Mean of the changed SBP from baseline after 4 weeks	4 weeks	No
Secondary	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	Percent of the patients achieving goal DBP and SBP after 4 weeks	4 weeks	No
Secondary	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	Percent of patients achieving goal of DBP	8 weeks	No
Secondary	Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy	Changed SBP from baseline after 8 weeks	8 weeks	No
Secondary	Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy	Change of hs-CRP from basline after 8 weeks	8 weeks	No
Secondary	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)	Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks	8 weeks	No
Secondary	Compliance Levels at 4 Weeks and 8 Weeks of Therapy	Percent of the number of returened pills to the number of prescrited pills	8 weeks	No