Status:
COMPLETED
A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension
Lead Sponsor:
Takeda
Conditions:
Essential Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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-536T...
Eligibility Criteria
Inclusion
- In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
- The participant has essential hypertension.
- The participant has an office sitting systolic blood pressure (SBP) of \<180 mmHg and office sitting diastolic blood pressure (DBP) of \< 110 mmHg at the start of the run-in period (Week -4). Participants receiving combined therapy with a 3-drug antihypertensive within 4 weeks prior to the start of the run-in period is required to have an office sitting SBP of \< 160 mmHg and an office sitting DBP of \< 100 mmHg.
- The participant's office sitting blood pressure at Week -2 and at the end of the run-in period (Week 0) need to be either:
- Participants without concurrent diabetes mellitus or chronic kidney disease (CKD)\*: Sitting SBP of ≥ 140 mmHg or sitting DBP of ≥ 90 mmHg
- Participants with concurrent diabetes mellitus or CKD\*: Sitting SBP of ≥ 130 mmHg or sitting DBP of ≥ 80 mmHg.
- Estimate glomerular filtration rate according to creatinine (eGFRcreat) of \<60 mL/min/1.73 m\^2, or urinary albumin (spot urine) of ≥30 μg/mL in laboratory tests performed at Week -2 of the run-in period, and diagnosed with CKD by the investigator or subinvestigator.
- The participant has an office sitting SBP of \< 160 mmHg and office sitting DBP of \< 100 mmHg at the end of the run-in period (Week 0).
- The participant is male or female, aged 20 years or older at the time of providing informed consent.
- The participant is an outpatient.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agree to use routinely adequate contraception from signing of informed consent through 1 month following the end of the study.
Exclusion
- The participant has received any study drugs within 12 weeks prior to the start of the run-in period.
- The participant has participated in another clinical study or a post-marketing study within 30 days prior to the start of the run-in period.
- The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g. spouse, parent, child, sibling), or may consent under duress.
- The participant requires taking prohibited concomitant drugs during the study.
- The participant has a history of hypersensitivity or allergies to TAK-536, AML, HCTZ, any thiazide diuretic or analog, any dihydropyridine drug, or any analog of TAK-536TCH.
- The participant is judged by the investigator or subinvestigator to be in danger of experiencing an excessive increase in blood pressure when changing or discontinuing premedication.
- The participant received combination therapy with antihypertensive drugs of the 3 ingredients contained in TAK-536TCH.
- The participant received combined therapy with antihypertensive drugs, including 4 or more components, within 4 weeks prior to the start of the run-in period.
- The participant has secondary or malignant hypertension.
- The participant has a difference of ≥ 20 mmHg between left and right arms in office sitting SBP at the start of the run-in period (Week -4).
- The participant has apparent white coat hypertension or exhibits a white coat effect.
- . The participant has a day-night reversed lifestyle, such as those working during the night.
- The participant has sleep apnea syndrome requiring treatment.
- The participant has any of the following cardiovascular diseases:
- Cardiac disease: Myocardial infarction\*, coronary arterial revascularization\*, severe valvular disorder, atrial fibrillation, any of the following conditions requiring treatment: angina pectoris, congestive heart failure, arrhythmia
- Cerebrovascular disorders: Cerebral infarction/cerebral hemorrhage\*, transient ischemic attack\*
- Vascular disease: Peripheral artery disease with intermittent claudication, artery dissection, aneurysm
- Advanced hypertensive retinopathy: With bleeding or exudate/papilledema\*\* \* Occurring or performed within 24 weeks of the start of the run-in period \*\* Observed within 24 weeks of the start of the run-in period
- The participant has a clinically apparent hepatic disorder (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at Week -2 of the run-in period ≥ 2.5 times the upper limit of normal (ULN).
- The participant has a clinically severe renal disorder (e.g., eGFRcreat in laboratory tests performed at Week -2 of run-in period \< 30 mL/minute/1.73 m\^2).
- The participant's body fluid sodium or potassium level is markedly low\* or high\*.
- \*Based on normal ranges
- The participant has gout or a history of gout within 24 weeks of the start of the run-in period or has hyperuricemia requiring drug treatment.
- The participant has uncontrolled diabetes (e.g., HbA1c ≥ 7.4% in laboratory tests performed at Week -2 of the run-in period).
- The participant has a malignant tumor.
- If female, the participant is pregnant or lactating or before giving informed consent, intending to become pregnant or donate ova during or within 1 month after participating in the study.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the run-in period.
- The participant who, in the opinion of the investigator or subinvestigator, is unsuitable for any other reason.
Key Trial Info
Start Date :
November 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2016
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT02277691
Start Date
November 7 2014
End Date
April 25 2016
Last Update
August 2 2017
Active Locations (38)
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1
Nagoya, Aichi-ken, Japan
2
Chiba, Chiba, Japan
3
Itojima-shi, Fukuoka, Japan
4
Kouriyama-shi, Fukushima, Japan