The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg
Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg
Korea University Ansan Hospital
Gyeonggi-do, Ansan-si, South Korea
Jeju National University Hospital
Jeju City, Aran, South Korea
Bundang Cha Hospital
Seongnam, Bundang-gu, South Korea
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Time frame: Baseline and week 8
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.
Each timepoint is as following: * Daytime: 06:00\~21:59 * Nighttime: 22:00\~05:59 * Morning: 06:00\~11:59
Time frame: Baseline and week 8
Change from baseline in the clinic mean blood pressure at week 8.
Time frame: Baseline and week 8
24hr ABPM and Clinic BP control at week 8.
\<24hr ABPM\> * 24hr mean BP: 24hr mean Systolic blood pressure(SBP)\<130mmHg and 24hr mean Diastolic blood pressure(DBP)\<80mmHg * Daytime BP: Daytime mean SBP\<135mmHg and Daytime mean DBP\<85mmHg * Night time BP: Night time mean SBP\<120mmHg and Night time mean DBP\<70mmHg \<Clinic BP\> : Mean sitting systolic blood pressure(MSSBP)\<140mmHg and Mean sitting diastolic blood pressure(MSDBP)\<90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP\<130mmHg and MSDBP\<80mmHg)
Time frame: Baseline and week 8
24hr ABPM and Clinic BP response at week 8.
\<24hr ABPM\> 24hr mean SBP and DBP reduction≥10mmHg \<Clinic BP\> MSSBP and MSDBP≥10mmHg
Time frame: Baseline and week 8
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Seoul University Bundang Hospital
Seongnam, Bundang-gu, South Korea
KyungHee University Medical Center
Seoul, Dongdaemun-gu, South Korea
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea
Kumi cha Hospital
Gumi, Gyeongsangbuk-do, South Korea
Seoul University Hospital
Seoul, Jongro-gu, South Korea
National Medical Center
Seoul, Jung-gu, South Korea
Kosin University Gospel Hospital
Busan, Seo-gu, South Korea
...and 1 more locations