CKD-828 Telmisartan Non-Responder Trial

Chong Kun Dang

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Telmisartan 80mg

Drug: CKD-828 40/5mg

Drug: CKD-828 40/2.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01426100

130HT11B

Details and patient eligibility

About

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.

Enrollment

183 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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