Clinical trial NCT02651870: 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
Official title: A Randomized, Double-blind, Multi-center, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 135
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Age of 19 or above
* Inadequately controlled Essential hypertension at Screening

  1. Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1

     * Mean sitDBP ≥ 95mmHg on target arm
  2. 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

Primary outcomes:
measure: The mean change of sitDBP(sitting diastolic blood pressure)
timeFrame: From baseline at week 8
Secondary outcomes:
measure: The mean change of sitDBP
timeFrame: From baseline to week 4
measure: The mean change of sitSBP
timeFrame: From baseline to week 4 and 8
measure: Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg
timeFrame: From baseline to week 8
measure: Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg
timeFrame: From baseline to week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: