Trial Outcomes & Findings for A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension (NCT NCT02277691)
NCT ID: NCT02277691
Last Updated: 2017-08-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
341 participants
Primary outcome timeframe
Baseline up to Week 52
Results posted on
2017-08-02
Participant Flow
Participants took part in the study at 31 investigative sites in Japan, from 07 November 2014 to 25 April 2016.
Participants with diagnosis of essential hypertension were enrolled in 1 treatment group:TAK-536CCB (TAK-536/ AML,20 mg/5 mg) in run-in period (Week -4 to 0).
Participant milestones
| Measure |
TAK-536TCH
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Overall Study
STARTED
|
341
|
|
Overall Study
COMPLETED
|
295
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
TAK-536TCH
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
33
|
|
Overall Study
Voluntary Withdrawal
|
7
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Used Other Antihypertensive Drug
|
1
|
Baseline Characteristics
A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension
Baseline characteristics by cohort
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
244 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
341 Participants
n=5 Participants
|
|
Height
|
164.1 cm
STANDARD_DEVIATION 8.51 • n=5 Participants
|
|
Weight
|
70.80 kg
STANDARD_DEVIATION 12.943 • n=5 Participants
|
|
BMI
|
26.20 kg/m^2
STANDARD_DEVIATION 3.883 • n=5 Participants
|
|
Smoking Classification
Never Smoked
|
116 Participants
n=5 Participants
|
|
Smoking Classification
Current Smoker
|
84 Participants
n=5 Participants
|
|
Smoking Classification
Ex-Smoker
|
141 Participants
n=5 Participants
|
|
History of Alcohol Consumption
|
120 Participants
n=5 Participants
|
|
Duration of Hypertension
|
9.42 years
STANDARD_DEVIATION 7.728 • n=5 Participants
|
|
Concurrent Diabetes Mellitus
|
90 Participants
n=5 Participants
|
|
Concurrent Chronic Kidney Disease
|
65 Participants
n=5 Participants
|
|
Office Sitting Systolic Blood Pressure (SBP)
|
143.7 mmHg
STANDARD_DEVIATION 8.23 • n=5 Participants
|
|
Office Sitting Diastolic Blood Pressure (DBP)
|
86.2 mmHg
STANDARD_DEVIATION 9.28 • n=5 Participants
|
|
Estimated Glomerular Filtration Rate According To Creatinine (eGFRcreat)
|
78.1 mL/min/1.73 m^2
STANDARD_DEVIATION 16.73 • n=5 Participants
|
|
Medical History
Cerebrovascular Disorder
|
13 Participants
n=5 Participants
|
|
Medical History
Cardiac Disease
|
9 Participants
n=5 Participants
|
|
Medical History
Vascular Disorder
|
1 Participants
n=5 Participants
|
|
Medical History
Hepatic Disorder
|
2 Participants
n=5 Participants
|
|
Medical History
Dyslipidemia
|
1 Participants
n=5 Participants
|
|
Medical History
Other Medical History
|
52 Participants
n=5 Participants
|
|
Concurrent Medical Conditions
Cerebrovascular Disorder
|
2 Participants
n=5 Participants
|
|
Concurrent Medical Conditions
Cardiac Disease
|
11 Participants
n=5 Participants
|
|
Concurrent Medical Conditions
Vascular Disorder
|
21 Participants
n=5 Participants
|
|
Concurrent Medical Conditions
Hepatic Disorder
|
43 Participants
n=5 Participants
|
|
Concurrent Medical Conditions
Dyslipidemia
|
174 Participants
n=5 Participants
|
|
Concurrent Medical Conditions
Other Concurrent Medical Conditions
|
292 Participants
n=5 Participants
|
|
Medication History (Antihypertensives)
ARBs
|
310 Participants
n=5 Participants
|
|
Medication History (Antihypertensives)
ACE Inhibitors
|
9 Participants
n=5 Participants
|
|
Medication History (Antihypertensives)
CCBs
|
313 Participants
n=5 Participants
|
|
Medication History (Antihypertensives)
Diuretics
|
66 Participants
n=5 Participants
|
|
Medication History (Antihypertensives)
β-blockers
|
19 Participants
n=5 Participants
|
|
Medication History (Antihypertensives)
Other Antihypertensives
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
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.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
289 Participants
|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
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.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Number of Participants With Markedly Abnormal Vital Signs Values
SBP (Standing) (>180mmHg)
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
SBP (Supine) (>180mmHg)
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
SBP (Standing) (<85mmHg)
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
DBP (Supine) (<50mmHg)
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
DBP (Standing) (>110mmHg)
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs Values
Office, Sitting Pulse (<50bpm)
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight
Weight decreased
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight
Weight increased
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)
Atrial fibrillation
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)
Sinus bradycardia
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)
QRS axis abnormal
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
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.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
RBC (< 0.8×LLN×10^6cells/μL)
|
5 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Hemoglobin (<0.8 × LLN g/dL)
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Hematocrit (<0.8 × LLN Percent)
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
ALT (>3 × ULN U/L)
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
AST (>3 × ULN U/L)
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Total Bilirubin (>2.0 mg/dL)
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Creatinine (>2.0 mg/dL)
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Blood Urea Nitrogen (>30 mg/dL)
|
20 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
GGT (>3 × ULN U/L)
|
14 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Eosinophils (>2 × ULN×10^3cells/μL)
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Uric Acid (>13.0 mg/dL)
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Total Cholesterol (>300 mg/dL)
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Triglycerides (>2.5 × ULN mg/dL)
|
29 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Potassium (<3.0 mEq/L)
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Sodium (<130 mEq/L)
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (End of Run-in Period, Week 0) and Weeks 12 (LOCF) and 52 (LOCF)Population: The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analyzed at the given timepoint.
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.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at Week 12 (LOCF), SBP
|
-14.4 mmHg
Standard Deviation 12.72
|
|
Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at Week 52 (LOCF), SBP
|
-13.9 mmHg
Standard Deviation 12.14
|
|
Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at Week 12 (LOCF), DBP
|
-8.6 mmHg
Standard Deviation 8.97
|
|
Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at Week 52 (LOCF), DBP
|
-8.3 mmHg
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Baseline (End of Run-in Period, Week 0), End of Week 12 and End of Treatment (Up to Week 52)Population: The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analysed at the given time-point.
The change in home morning SPB and DBP measured at End of Week 12, End of Treatment (Up to Week 52) relative to baseline.
Outcome measures
| Measure |
TAK-536TCH
n=341 Participants
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at End of Week 12, Morning SBP
|
-13.9 mmHg
Standard Deviation 10.67
|
|
Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at EOT (Up to Week 52), Morning SBP
|
-12.4 mmHg
Standard Deviation 11.75
|
|
Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at End of Week 12, Morning DBP
|
-7.9 mmHg
Standard Deviation 6.59
|
|
Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit
Change at EOT (Up to Week 52), Morning DBP
|
-6.9 mmHg
Standard Deviation 7.23
|
Adverse Events
TAK-536TCH
Serious events: 20 serious events
Other events: 195 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-536TCH
n=341 participants at risk
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.59%
2/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.29%
1/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.59%
2/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
TAK-536TCH
n=341 participants at risk
For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast.
For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg, orally, once daily, before or after breakfast.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
31.1%
106/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood uric acid increased
|
25.2%
86/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
18/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
18/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.3%
18/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.6%
19/341 • Baseline up to Week 52
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER