To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg
Korean University Guro Hospital
Seoul, Guro-gu, South Korea
RECRUITINGMyongji Hospital
Goyang, Gyeonggi-di, South Korea
RECRUITINGChange from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
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
* 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\<140mmHg and Mean sitting diastolic blood pressure\<90mmHg
Time frame: Baseline and week 8
Morning BP Surge
The morning BP surge was calculated as the morning BP minus the lowest BP. Morning BP was defined as the average BP during the first 2 h after waking. The lowest BP was defined as the average of three BP readings focused on the lowest night-time reading (that is, the lowest reading plus the readings immediately before and after)
Time frame: Baseline and week 8
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Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGBundang Jesaeng Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGDaegu Catholic University Medical Center
Dae-gu, Gyeongsangbuk-do, South Korea
RECRUITINGKeimyung University Dongsan Medical Center
Daegu, Gyeongsangbuk-do, South Korea
RECRUITINGYeungnam University Medical Center
Daegu, Gyeongsangbuk-do, South Korea
RECRUITINGCheju Halla General Hospital
Jeju City, Jeju Special Self-Governing, South Korea
RECRUITINGDong-A University Hospital
Busan, Seo-gu, South Korea
RECRUITINGPusan National University Hospital
Busan, Seo-gu, South Korea
RECRUITING