CKD-828 Telmisartan Non-Responder Trial

Last updated: September 11, 2012
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Williams Syndrome

Stress

Treatment

N/A

Clinical Study ID

NCT01426100
130HT11B
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18 years or older

  • diagnosis of essential hypertension and blood pressure not adequatelycontrolled(inadequate control defined as seated diastolic blood pressure(DBP)>= 90mmHgif on existing antihypertensive treatment of seated DBP >= 100mmHg if treatment naive)

  • failure to respond to four weeks treatment with telmisartan 40mg(failure to responddefined as seated DBP >= 90mmHg)

  • willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  • mean seated DBP >= 120mmHg and/or mean seated SBP >= 200mmHg during run-in treatmentor mean seated DBP >= 120mmHg and/or mean seated SBP >= 180mmHg at the randomizationvisit

  • known or suspected secondary hypertension(ex. aortic coarctation, Primaryhyperaldosteronism, renal artery stenosis, pheochromocytoma)

  • has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina ormyocardial infarction, arrhythmia within the past three months

  • has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6months

  • Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control asdefined 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 ulcersneed to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function suchas 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

Study Design

Total Participants: 183
Study Start date:
August 01, 2011
Estimated Completion Date:
August 31, 2012

Connect with a study center

  • Kandong Sacred Heart Hospital

    Anyang,
    Korea, Republic of

    Site Not Available

  • Daegu Catholic University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • DonGuk University Ilsan Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • National Health Insurance Corporation Ilsan Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Inchon,
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Bundang Cha Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • St. Paul's Hospital, The catholic University of Korea

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.