The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering diastolic blood pressure in patients who missed a dose of their medication, as measured by ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
440
Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose
measured by ambulatory blood pressure monitoring (ABPM)
Time frame: Baseline, Day 41, Day 55
Change in mean DBP during the last 6 hours of the 24 hour dosing interval
Time frame: up to 8 weeks
Change in 24-hour mean systolic blood pressure (SBP) after a missed dose
Time frame: Baseline, Day 41, Day 55
Change in mean SBP during the last 6 hours of the 24-hour dosing interval
Time frame: up to 8 weeks
Change in pulse pressure (PP)
Time frame: up to 8 weeks
Change in 24-hour mean DBP after an active dose of study medication
Time frame: up to 8 weeks
Change in 24-hour mean SBP after an active dose of study medication
Time frame: up to 8 weeks
Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose
Time frame: up to 8 weeks
Change in the mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after an active dose of study medication
Time frame: up to 8 weeks
Responder rate measured by ABPM after a missed dose of study medication
* ABPM DBP "control" (24-hour mean DBP \< 80 mmHg), * ABPM DBP "response" (24-hour mean DBP \< 80 mmHg and/or reduction from baseline ≥ 10 mmHg), * ABPM SBP "response" (24-hour mean SBP \< 130 mmHg and/or reduction from baseline ≥ 10 mmHg)
Time frame: Baseline, Day 41, Day 55
Responder rate measured by ABPM after an active dose of study medication
* ABPM DBP "control" (24-hour mean DBP \< 80 mmHg), * ABPM DBP "response" (24-hour mean DBP \< 80 mmHg and/or reduction from baseline ≥ 10 mmHg), * ABPM SBP "response" (24-hour mean SBP \< 130 mmHg and/or reduction from baseline ≥ 10 mmHg)
Time frame: up to 8 weeks
Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication
* DBP "control" (DBP \< 90 mmHg), * DBP "response" (DBP \< 90 mmHg and/or fall of ≥ 10 mmHg), * SBP "response" (SBP \< 140 mmHg and/or fall of ≥ 10 mmHg), * BP "normal" (SBP \< 130 mmHg and DBP \< 85 mmHg), * BP "normal / high normal" (SBP \< 140 mmHg and DBP \< 90 mmHg).
Time frame: Baseline, Day 41, Day 55
Responder rate in- clinic manual trough cuff measurements after an active dose of study medication
* DBP "control" (DBP \< 90 mmHg), * DBP "response" (DBP \< 90 mmHg and/or fall of ≥ 10 mmHg), * SBP "response" (SBP \< 140 mmHg and/or fall of ≥ 10 mmHg), * BP "normal" (SBP \< 130 mmHg and DBP \< 85 mmHg), * BP "normal / high normal" (SBP \< 140 mmHg and DBP \< 90 mmHg).
Time frame: up to 8 weeks
Number of patients with adverse events
Time frame: up to 8 weeks
Change in 24-hour Pulse Pressure (PP) after a missed dose
Time frame: Baseline, Day 41, Day 55
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