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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Candesartan cilexetil 16mg/HCT combination therapy

Candesartan Cilexetil 32 mg/HCT combination therapy

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

Candesartan Effect in Second stage Arterial hypertension

Research Site

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

Mean of the changed DBP from baseline after 4 weeks

Age Continuous

Gender, Male/Female

Changes in mean sitting DBP from baseline after 4 weeks of therapy

Mean of the changed SBP from baseline after 4 weeks

Changes in mean sitting SBP from baseline after 4 weeks of therapy

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 4 weeks of therapy

Percent of patients achieving goal of DBP

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

Changes in mean sitting SBP from baseline after 8 weeks of therapy

Change of hs-CRP from basline after 8 weeks

Changes in hs-CRP level from baseline after 8 weeks of therapy

Occurred number of AE and disconinuation of study medication due to the AE 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)

Percent of the number of returened pills to the number of prescrited pills

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 Name: HCTZ Other Name: 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 Name: HCTZ Other Name: Diazide Drug: Candesartan Cilexetil Candesartan Cilexetil 32 mg oral Other Name: Atacand

Candesartan Effect in Second stage Arterial hypertension - CAESAR

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=307&filename=CSR-D2452L00016.pdf

CSR-D2452L00016.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator