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| Tracking Information | |||||
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| First Received Date ICMJE | November 22, 2005 | ||||
| Last Updated Date | September 24, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension. | ||||
| Original Primary Outcome Measures ICMJE |
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension | ||||
| Change History | Complete list of historical versions of study NCT00257491 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Smooth Index for DBP and SBP Change from the baseline in the ABPM endpoint: 24 hour mean, daytime mean , nighttime mean, morning mean, last 6-hours of the dosing interval mean SBP, DBP,MAP and HR. | ||||
| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) Ambulatory Blood Pressure Monitoring (ABPM) Study in China | ||||
| Official Title ICMJE | An Open-label Study to Evaluate the Trough and Peak Effect of Once Daily Micardis Plus (Telmisartan 80mg / Hydrochlorothiazide 12.5 mg) by 24 ABPM in Patients With Mild to Moderate Essential Hypertension | ||||
| Brief Summary | To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension. |
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| Detailed Description | This study is designed as an open label study. After a 2-week placebo run-in phase, qualified patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of active treatment. Study Hypothesis: The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 - DeltaHM8). Comparison(s): To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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 | 20 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion). Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00257491 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 502.488 | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | July 2009 | ||||
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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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