CKD-828 Telmisartan Non-Responder Trial
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
1 other identifier
interventional
183
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Aug 2011
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 30, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 13, 2012
September 1, 2012
9 months
August 30, 2011
September 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Sitting Diastolic Blood Pressure (MSDBP)
After 8 weeks of treatment
Secondary Outcomes (4)
Mean Sitting Diastolic Blood Pressure (MSDBP)
After 4 weeks of treatment
Mean Sitting Systolic Blood Pressure (MSSBP)
After 4 weeks and 8 weeks of treatment
Response rate
After 4 weeks and 8 weeks of treatment
Control rate
After 4 weeks and 8 weeks of treatment
Study Arms (3)
CKD-828 40/2.5mg
EXPERIMENTALCKD-828 40/5mg
EXPERIMENTALTelmisartan 80mg
ACTIVE COMPARATORInterventions
Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Kandong Sacred Heart Hospital
Anyang, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
DonGuk University Ilsan Hospital
Goyang, South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang, South Korea
Gachon University Gil Medical Center
Inchon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Bundang Cha Medical Center
Seoul, South Korea
Ewha Womans University Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Inje University Ilsan Paik Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Soon Chun Hyang University Hospital
Seoul, South Korea
St. Paul's Hospital, The catholic University of Korea
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
August 31, 2011
Study Start
August 1, 2011
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
September 13, 2012
Record last verified: 2012-09