Phase
Condition
Circulation Disorders
Williams Syndrome
Stress
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Kandong Sacred Heart Hospital
Anyang,
Korea, Republic ofSite Not Available
Daegu Catholic University Medical Center
Daegu,
Korea, Republic ofSite Not Available
Keimyung University Dongsan Medical Center
Daegu,
Korea, Republic ofSite Not Available
DonGuk University Ilsan Hospital
Goyang,
Korea, Republic ofSite Not Available
National Health Insurance Corporation Ilsan Hospital
Goyang,
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Inchon,
Korea, Republic ofSite Not Available
Chonbuk National University Hospital
Jeonju,
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofSite Not Available
Bundang Cha Medical Center
Seoul,
Korea, Republic ofSite Not Available
Ewha Womans University Hospital
Seoul,
Korea, Republic ofSite Not Available
Gangnam Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Inje University Ilsan Paik Hospital
Seoul,
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul,
Korea, Republic ofSite Not Available
Kyung Hee University Medical Center
Seoul,
Korea, Republic ofSite Not Available
Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital
Seoul,
Korea, Republic ofSite Not Available
St. Paul's Hospital, The catholic University of Korea
Seoul,
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon,
Korea, Republic ofSite Not Available

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