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Completed

NCT Number: NCT01128322

CKD-828 Primary Hypertension Trial(Dose-selection)

The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 years or older
  • stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg
  • ability to provide written informed consent

Exclusion criteria

  • severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg
  • known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
  • has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
  • known severe or malignant retinopathy
  • hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5
  • acute or chronic inflammatory status need to treatment
  • need to additional antihypertensive drugs during the study
  • need to concomitant medications known to affect blood pressure during the study
  • history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
  • known hypersensitivity related to either study drug
  • history of drug or alcohol dependency
  • any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
  • cannot swallow investigational products
  • administration of other study drugs within 4 weeks prior to randomization
  • premenopausal women(last menstration < 1year) not using adequte contraception, pregnant or breast-feeding
  • history of malignancy including leukemia and lymphoma within the past 5 years
  • in investigator's judgment

Treatment and study plan

S-Amlodipine, Telmisartan

Drug

S-amlodipine

Drug

Telmisartan

Drug

Placebo

Drug

Primary outcomes

  1. Mean Sitting Diastolic Blood Pressure(MSDBP)

    Time frame: After 8 weeks of treatment

Secondary outcomes

  1. Mean Sitting Diastolic Blood Pressure(MSDBP)

    Time frame: After 4 weeks of treatment

  2. Mean Sitting Systolic Blood Pressure(MSSBP)

    Time frame: After 4 weeks and 8 weeks of treatment

  3. Response rate

    Time frame: After 4 weeks and 8 weeks of treatment

    Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg

  4. Control rate

    Time frame: After 4 weeks and 8 weeks of treatment

    Reduction SBP < 140mmHg, DBP < 90mmHg

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Double-blind, Multi-center, Multi-factorial, Phase 2 Trial to Evaluate the Efficacy and Safety of S-Amlodipine/Telmisartan Combined or Alone and Select Better Dose of CKD-828 in Patients With Essential Hypertension

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 21, 2010
Registry last updated
Apr 26, 2011

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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