Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
Phase 3
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT02651870
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
-
Age of 19 or above
-
Inadequately controlled Essential hypertension at Screening
-
Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1
- Mean sitDBP ≥ 95mmHg on target arm
-
Taking antihypertensive drug but not controlled
- Mean sitDBP ≥ 90mmHg on target arm
-
-
Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy
- Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
-
Ability to provide written informed consent
Exclusion Criteria
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
- Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patient with congestive heart failure(NYHA class III, IV)
- Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
- History of stroke, cerebral hemorrhage within 6 months
- Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c > 8.5%
- History of severe or malignant retinopathy
- AST/ALT > UNL*3, Serum creatinine > UNL*1.5, K > 5.5mEq/L
- Patient with acute or chronic inflammatory(treatment required) status
- Patient who need to take antihypertensive drug besides Investigational products
- Patient must be treated with medications prohibited for concomitant use during the study period
- History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- Hypersensitive to Candesartan/Amlodipine
- Patient who are dependent on drugs or alcohol within 6 months
- History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- Patients treated with other investigational product within 30 days at first time taking the investigational product
- Women with pregnant, breast-feeding
- History of malignant tumor within 5 years
- Not eligible to participate for the study at the discretion of investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Candesartan 16mg + Amlodipine 5mg Candesartan 16mg Candesartan 16mg + Amlodipine 5mg, po, q.d. Candesartan 16mg + Amlodipine 5mg Amlodipine 5mg Candesartan 16mg + Amlodipine 5mg, po, q.d. Candesartan 16mg + Amlodipine 10mg Candesartan 16mg Candesartan 16mg + Amlodipine 10mg, po, q.d. Candesartan 16mg Candesartan 16mg Candesartan 16mg, po, q.d. Candesartan 16mg + Amlodipine 10mg Amlodipine 10mg Candesartan 16mg + Amlodipine 10mg, po, q.d.
- Primary Outcome Measures
Name Time Method The mean change of sitDBP(sitting diastolic blood pressure) From baseline at week 8
- Secondary Outcome Measures
Name Time Method Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg From baseline to week 8 The mean change of sitDBP From baseline to week 4 The mean change of sitSBP From baseline to week 4 and 8 Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg From baseline to week 8
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of