Candesartan Effect in Second Stage Arterial Hypertension

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Stage II Hypertension

Intervention / Treatment
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* Drug: Candesartan Cilexetil
* Drug: Hydrochlorothiazide
* Drug: Candesartan Cilexetil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Candesartan cilexetil 16mg monotherapy | Drug: Candesartan Cilexetil<br>* Candesartan Cilexetil 16 mg oral<br>* Other names: Atacand;|
| Experimental: 2<br>Candesartan cilexetil 16mg/HCT combination therapy | Drug: Candesartan Cilexetil<br>* Candesartan Cilexetil 16 mg oral<br>* Other names: Atacand;Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide 12.5 mg<br>* Other names: Diazide;|
| Active Comparator: 3<br>candesartan cilexetil 32mg monotherapy | Drug: Candesartan Cilexetil<br>* Candesartan Cilexetil 32 mg oral<br>* Other names: Atacand;|
| Experimental: 4<br>Candesartan Cilexetil 32 mg/HCT combination therapy | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide 12.5 mg<br>* Other names: Diazide;Drug: Candesartan Cilexetil<br>* Candesartan Cilexetil 32 mg oral<br>* Other names: Atacand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy | Mean of the changed DBP from baseline after 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy | Mean of the changed SBP from baseline after 4 weeks | 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 | Percent of the patients achieving goal DBP and SBP after 4 weeks | 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 | Percent of patients achieving goal of DBP | 8 weeks | 
| Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy | Changed SBP from baseline after 8 weeks | 8 weeks | 
| Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy | Change of hs-CRP from basline after 8 weeks | 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) | Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks | 8 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candesartan Cilexetil, hydrochlorothiazide, severe hypertension