The purpose of this study is to evaluate the safety of long-term administration of TAK-536, amlodipine (AML), and hydrochlorothiazide (HCTZ) in participants with essential hypertension.
The drug being tested in this study is called TAK-536TCH. TAK-536TCH is being tested to treat people who have essential hypertension. The study looked at effectiveness and long-term safety of TAK-536TCH in people who took TAK-536CCB in addition to standard care. The study enrolled 341 patients. Participants received: * TAK-536CCB (as TAK-536/AML, 20 mg/5 mg) in run-in period, * TAK-536TCH (as TAK-536/ AML/HCTZ, 20 mg/5 mg/12.5 mg) in treatment period * TAK-536CCB and HCTZ 12.5 mg in treatment period All participants were asked to take tablets at the same time each day throughout the study. This multi-center trial was conducted in Japan. The overall time to participate in this study was 56 weeks (4 weeks run-in period and 52 weeks treatment period). Participants made multiple visits to the clinic during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
341
TAK-536TCH tablets
TAK-536CCB tablets
HCTZ tablets
Unnamed facility
Nagoya, Aichi-ken, Japan
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: Baseline up to Week 52
Number of Participants With Markedly Abnormal Vital Signs Values
Vital signs included supine and standing systolic and diastolic blood pressure (SBP and DBP) respectively and office sitting pulse. Vital signs were considered abnormal if they were beyond the values defined in categories.
Time frame: Baseline up to Week 52
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight
Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.
Time frame: Baseline up to Week 52
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)
Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.
Time frame: Baseline up to Week 52
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Itojima-shi, Fukuoka, Japan
Unnamed facility
Kouriyama-shi, Fukushima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Amagasaki-shi, Hyōgo, Japan
Unnamed facility
Tsukuba, Ibaragi, Japan
Unnamed facility
Morioka, Iwate, Japan
Unnamed facility
Sakaide-shi, Kagawa-ken, Japan
Unnamed facility
Takamatsu, Kagawa-ken, Japan
...and 28 more locations
The number of participants with any markedly abnormal clinical laboratory test values collected throughout study. RBC = Red blood cells, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit. Laboratory vallues were considered abnormal if they were beyond the values defined in categories.
Time frame: Baseline up to Week 52
Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
The change in office trough SBP and DBP measured at Weeks 12 last observation was carried forward (LOCF) and 52 (LOCF) relative to baseline. Sitting blood pressure was measured at least 3 times. Each measurement session ended once blood pressure was found stable at 2 consecutive measurements. The average of the last 2 measurements of office sitting blood pressure was used.
Time frame: Baseline (End of Run-in Period, Week 0) and Weeks 12 (LOCF) and 52 (LOCF)
Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
The change in home morning SPB and DBP measured at End of Week 12, End of Treatment (Up to Week 52) relative to baseline.
Time frame: Baseline (End of Run-in Period, Week 0), End of Week 12 and End of Treatment (Up to Week 52)