The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild to moderate hypertension who do not reach target blood pressure following 4 weeks of treatment with amlodipine monotherapy.
The drug being tested in this study is called TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination). This study will look at blood pressure in Chinese participants with grade 1 or 2 essential hypertension. The study will enroll approximately 370 patients. Prior to the start of study treatment, participants will undergo run-in period of 2 weeks followed by single-blind treatment period of 4 weeks. Upon completion of single-blind treatment period, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Amlodipine 5 mg * TCV-116CCB (Candesartan 8 mg Plus Amlodipine 5 mg) All participants will be asked to take one tablet/capsule at the same time each day throughout the study up to 8 weeks. This multicenter trial will be conducted China. The overall time to participate in this study is 19 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit 14 days after receiving their last dose of drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Amlodipine Capsules
TCV-116CCB Tablets
Amlodipine placebo-matching capsules
Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure (SBP) at Week 8
The change between trough SBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Time frame: Baseline and Week 8
Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure (DBP) at Week 8
The change between trough DBP measured at Week 8 relative to baseline. It is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Time frame: Baseline and Week 8
Percentage of Participants who Achieved Target Blood Pressure at Week 8
Target blood pressure is defined as trough, sitting clinic SBP \<140 mm Hg, trough, sitting, clinic DBP \<90 mm Hg or achieving both trough, sitting clinic SBP (\<140 mm Hg) and DBP targets (\<90 mm Hg).
Time frame: Week 8
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TCV-116CCB 8/5 mg placebo-matching tablets
Fuwai Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Daqing first hospital
Daqing, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
...and 15 more locations