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CKD-828 Telmisartan Non-Responder Trial

Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: CKD-828 40/2.5mg (Drug); CKD-828 40/5mg (Drug); Telmisartan 80mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Chong Kun Dang Pharmaceutical


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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Sitting Diastolic Blood Pressure (MSDBP)

Secondary outcome:

Mean Sitting Diastolic Blood Pressure (MSDBP)

Mean Sitting Systolic Blood Pressure (MSSBP)

Response rate

Control rate


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Kandong Sacred Heart Hospital, Anyang, Korea, Republic of

Daegu Catholic University Medical Center, Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of

DonGuk University Ilsan Hospital, Goyang, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital, Goyang, Korea, Republic of

Gachon University Gil Medical Center, Inchon, Korea, Republic of

Chonbuk National University Hospital, Jeonju, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

Bundang Cha Medical Center, Seoul, Korea, Republic of

Ewha Womans University Hospital, Seoul, Korea, Republic of

Gangnam Severance Hospital, Seoul, Korea, Republic of

Inje University Ilsan Paik Hospital, Seoul, Korea, Republic of

Korea University Guro Hospital, Seoul, Korea, Republic of

Kyung Hee University Medical Center, Seoul, Korea, Republic of

Severance Hospital, Seoul, Korea, Republic of

Soon Chun Hyang University Hospital, Seoul, Korea, Republic of

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

Ajou University Hospital, Suwon, Korea, Republic of

Additional Information

Starting date: August 2011
Last updated: September 11, 2012

Page last updated: August 23, 2015

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