To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
259
1235.16.004 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan
1235.16.006 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
1235.16.005 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
Percentage of Participants Who Experienced Adverse Events
An adverse event is defined as any untoward medical occurrence
Time frame: 52 weeks
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Time frame: First administration of study treatment to 24 hours post last dosing of study treatment.
Change From Baseline in Seated Diastolic Blood Pressure at Week 8
mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Time frame: Baseline and week 8
Change From Baseline in Seated Systolic Blood Pressure at Week 8
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Time frame: Baseline and week 8
Seated DBP Control Rate at Trough After 8 Weeks
Percentage of patients whose DBP \<90 mmHg after 8 weeks of treatment
Time frame: week 8
Seated SBP Control Rate at Trough After 8 Weeks
Percentage of patients whose SBP \<140 mmHg after 8 weeks of treatment
Time frame: Week 8
Change From Baseline in Seated Diastolic Blood Pressure
Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
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1235.16.003 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.16.001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1235.16.002 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
Time frame: Baseline and week 20 / week 48
Change From Baseline in Seated Systolic Blood Pressure
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Time frame: Baseline and week 20 / week 48
Seated DBP Control Rate at Trough After 6 and 12 Months
Percentage of patients whose DBP \<90 mmHg.
Time frame: 6 months and 12 months
Seated SBP Control Rate at Trough After 6 and 12 Months
Percentage of patients whose SBP \<140 mmHg
Time frame: 6 months and 12 months
Seated DBP Response Rate at Trough
Percentage of patients whose DBP \<90 mmHg or decreased from pseudo-baseline by \>=10 mmHg at 6 months and 12 months
Time frame: 6 months and 12 months
Seated SBP Response Rate at Trough
Percentage of patients whose SBP \<140 mmHg or decreased deom pseudo-baseline by \>=20 mmHg after 6 and 12 months
Time frame: 6 months and 12 months
Seated Blood Pressure Normalisation at Trough
Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months: Optimal: SBP \<120 mmHg and DBP \<80 mmHg Normal: SBP \>=120 mmHg or DBP \>=80 mmHg and SBP \<130 mmHg or DBP \<85 mmHg High normal: SBP \>=130 mmHg or DBP \>=85 mmHg and SBP \<140 mmHg or DBP \<90 mmHg No: SBP \>=140 mmHg or DBP \>=90 mmHg
Time frame: 6 months and 12 months