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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

C

Chong Kun Dang

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: Candesartan 16mg
Drug: Amlodipine 5mg
Drug: Amlodipine 10mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02651870
144HT14020

Details and patient eligibility

About

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

Enrollment

135 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

135 participants in 3 patient groups

Candesartan 16mg + Amlodipine 5mg
Experimental group
Description:
Candesartan 16mg + Amlodipine 5mg, po, q.d.
Treatment:
Drug: Amlodipine 5mg
Drug: Candesartan 16mg
Candesartan 16mg + Amlodipine 10mg
Experimental group
Description:
Candesartan 16mg + Amlodipine 10mg, po, q.d.
Treatment:
Drug: Candesartan 16mg
Drug: Amlodipine 10mg
Candesartan 16mg
Active Comparator group
Description:
Candesartan 16mg, po, q.d.
Treatment:
Drug: Candesartan 16mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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