Candesartan Effect in Second Stage Arterial Hypertension

Phase 4

Completed

• Conditions: Stage II Hypertension
• Interventions: Drug: Candesartan Cilexetil; Drug: Hydrochlorothiazide

• Registration Number: NCT00621153
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study First Submitted: 2008-01-24
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-04
• Results First Submitted: 2010-02-24
• Results First Submitted QC: 2010-02-24
• Last Update Submitted: 2010-02-24
• Results First Posted: 2010-03-23
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Candesartan Cilexetil	Candesartan cilexetil 16mg monotherapy
2	Hydrochlorothiazide	Candesartan cilexetil 16mg/HCT combination therapy
4	Hydrochlorothiazide	Candesartan Cilexetil 32 mg/HCT combination therapy
4	Candesartan Cilexetil	Candesartan Cilexetil 32 mg/HCT combination therapy
2	Candesartan Cilexetil	Candesartan cilexetil 16mg/HCT combination therapy
3	Candesartan Cilexetil	candesartan cilexetil 32mg monotherapy

Primary Outcome Measures

Name	Time	Method
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy	4 weeks	Mean of the changed DBP from baseline after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy	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	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	8 weeks	Percent of patients achieving goal of DBP
Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy	8 weeks	Changed SBP from baseline after 8 weeks
Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy	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)	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	8 weeks	Percent of the number of returened pills to the number of prescrited pills

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of