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Completed

NCT Number: 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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan 16mg

Drug

Amlodipine 5mg

Drug

Amlodipine 10mg

Drug

Primary outcomes

  1. The mean change of sitDBP(sitting diastolic blood pressure)

    Time frame: From baseline at week 8

Secondary outcomes

  1. The mean change of sitDBP

    Time frame: From baseline to week 4

  2. The mean change of sitSBP

    Time frame: From baseline to week 4 and 8

  3. Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg

    Time frame: From baseline to week 8

  4. Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg

    Time frame: From baseline to week 8

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2016
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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