The purpose of this study is to compare the different dose of DMTA07 (DM) combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.
To compare the different dose of DM combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy. The purpose of this study is to compare the antihypertensive efficacy and tolerability of different dose of DM combines with amlodipine treatment, further to explore the optimized combination dose of DM.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
111
Amlodipine 5 mg + DMTA07 0mg, once daily
Amlodipine 5 mg + DMTA07 2.5mg, once daily
Amlodipine 5 mg + DMTA07 7.5mg, once daily
E-DA Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
*SBP reduction=SBP each visit- SBPvisit2
The primary objective of this study is to compare the sitting systolic blood pressure (mmHg) reduction\* between four dose regimens, the baseline is defined as the actual SBP value after 2 weeks of amlodipine run-in period
Time frame: 14 weeks
The secondary objectives of the study include: Efficacy/Safety
Efficacy: To compare the sitting diastolic blood pressure (mmHg) reduction\* between four dose regimens, the baseline is defined as the actual DBP value after 2 weeks of amlodipine run-in period To evaluate the percentage of SBP reduction in four treatment regimens To evaluate the changes of blood pressure (mmHg) in different clusters; such as diabetes etc. Safety: To evaluate the pulse rate changes To evaluate incidences of adverse events To evaluate the change of laboratory test results from baseline
Time frame: 14 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Amlodipine 5 mg + DMTA07 30mg, once daily
Cheng Hsin General Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan