A Phase 3 interventional study of Telmisartan and Telmisartan/HCTZ in Hypertension, sponsored by Boehringer Ingelheim. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-11.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
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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This study's enrollment of 29 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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History of mild-to-moderate essential hypertension defined by a mean seated DBP >= 95 and \<= 109 mmHg, and SBP \< 180mmHg measured by manual cuff sphygmomanometer at visit 2.
Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg).
5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion).
Exclusion Criteria:
Pre-menopausal women (last menstruation \<= 1 year prior to start of screening):
Any woman:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
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.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim