An observational study in Hypertension, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-09-17.
Sponsored by Boehringer Ingelheim · Observational
The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 5,248 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hypertensive population under real life clinical practice in an ambulatory setting
Exclusion Criteria:
Drug: Telmisartan · Drug: Telmisartan hydrochlorothiazide
Also known as: Micardis®
Also known as: Micardis Plus®
Change of degree of Blood Pressure (BP) control in the early morning hours
Time frame: 8 weeks of treatment
Change from baseline in mSBP and mDBP by HBPM in the early morning
BP control during the morning time-periods (6:00 to 11:59), BP \< 135/85 mmHg (HBPM: mean of morning measurements)
Time frame: Baseline, after 8 weeks of treatment
Change from baseline in office BP control rates
Time frame: Baseline, after 8 weeks
Change from baseline in office BP response rates
Time frame: Baseline, after 8 weeks
Reduction in mSBP and mDBP by OBPM
Time frame: Baseline, after 8 weeks
Number of patients with adverse events
Time frame: up to 8 weeks
Global Assessment of tolerability by investigator on a 6-point scale
Time frame: after 8 weeks
Global assessment efficacy by investigator on 6-point scale
Time frame: after 8 weeks
No study locations are listed for this record.
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim