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Completed

NCT Number: NCT01426100

CKD-828 Telmisartan Non-Responder Trial

The aim of the present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kandong 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
  • diagnosis of essential hypertension and blood pressure not adequately controlled(inadequate control defined as seated diastolic blood pressure(DBP)>= 90mmHg if on existing antihypertensive treatment of seated DBP >= 100mmHg if treatment naive)
  • failure to respond to four weeks treatment with telmisartan 40mg(failure to respond defined as seated DBP >= 90mmHg)
  • willing and able to provide written informed consent

Exclusion criteria

  • mean seated DBP >= 120mmHg and/or mean seated SBP >= 200mmHg during run-in treatment or mean seated DBP >= 120mmHg and/or mean seated SBP >= 180mmHg at the randomization visit
  • 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 Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
  • nown 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 within 6 months
  • 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, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding
  • administration of other study drugs within 30 days prior to randomization
  • premenopausal women(last menstruation < 1year) not using adequate 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

CKD-828 40/2.5mg

Drug

Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg

CKD-828 40/5mg

Drug

Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg

Telmisartan 80mg

Drug

Telmisartan 80mg monotherapy

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, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(CKD-828) Versus Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 31, 2011
Registry last updated
Sep 13, 2012

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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