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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 23, 2008 | ||||||||
| Last Updated Date | February 5, 2008 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index. [ Time Frame: app. 3 monthly ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00607633 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH | ||||||||
| Official Title ICMJE | Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy | ||||||||
| Brief Summary | The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 686 | ||||||||
| Completion Date | October 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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| Gender | |||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00607633 | ||||||||
| Responsible Party | Andrea Pahor, AstraZeneca Germany | ||||||||
| Study ID Numbers ICMJE | NIS-CGE-ATA-2007/2 | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | January 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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