Clinical trial · Interventional
Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
A Randomized, Double-Blind, Multicenter, Phase 2/3 Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB (Fix-dose Combination of Azilsartan and Amlodipine) and Hydrochlorothiazide in Comparison With TAK-536CCB or Hydrochlorothiazide Monotherapy in Patients With Grade I or II Essential Hypertension
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Grade I or II Essential Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrochlorothiazide | Drug | — | UNRESOLVED |
| TAK-536CCB | Drug | — | UNRESOLVED |
| TAK-536CCB + Hydrochlorothiazide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- TAK-536CCB 20 mg/5 mg +Placebo (dual therapy)
- description
- TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide (HCTZ) placebo for 10 weeks
- interventionNames
- Drug: TAK-536CCB
- type
- EXPERIMENTAL
- label
- TAK-536CCB 20 mg/5 mg +HCTZ 6.25 mg (triple therapy)
- description
- TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo (triple therapy) for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 6.25 mg for the remaining 8 weeks.
- interventionNames
- Drug: TAK-536CCB + Hydrochlorothiazide
- type
- EXPERIMENTAL
- label
- TAK-536CCB 20 mg/5 mg +HCTZ 12.5 mg (triple therapy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Grade I or II essential hypertension. 2. An office sitting systolic blood pressure of ≥ 150 and \< 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and \< 110 mmHg during the placebo run-in period at Week -2 and Week 0. 3. Male or female aged 20 years or older at the time of providing informed consent. 4. Outpatient. Exclusion Criteria: 1. Secondary hypertension, grade III hypertension or malignant hypertension. 2. An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4. 3 Evident white coat hypertension or white coat phenomenon. 4. Day-night reversed lifestyle, such as night-time workers. 5. Sleep apnea syndrome requiring treatment. 6. Have any of the cardiovascular disease or symptoms listed below: * Heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia. * Cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period). * Vascular diseases: peripheral arterial disease with intermittent claudication, artery dissection, aneurysm * Advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period). 7\. Clinically significant hepatic disorder. 8. Clinically significant renal impairment. 9. Significantly low or high Potassium or Sodium levels. 10. Complicated by gout, or had a past history of gout within 24 weeks prior to the initiation of the placebo run-in period, or complicated by hyperuricemia requiring medication. 11\. Diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus. 12\. Have a malignant tumor.
References
Publications (0)
Data not yet available