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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: CKD-828 40/2.5mg; Drug: CKD-828 40/5mg; Drug: Telmisartan 80mg

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Kandong Sacred Heart Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Goyang, Korea, Republic of
    • Donguk University Ilsan Hospital
  • Goyang, Korea, Republic of
    • National Health Insurance Corporation Ilsan Hospital
  • Inchon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Hospital
  • Seoul, Korea, Republic of
    • Bundang Cha Medical Center
  • Seoul, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Seoul, Korea, Republic of
    • Soon Chun Hyang University Hospital
  • Seoul, Korea, Republic of
    • St. Paul's Hospital, The Catholic University of Korea
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-828 40/2.5mg	Drug: CKD-828 40/2.5mg; Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg
Experimental: CKD-828 40/5mg	Drug: CKD-828 40/5mg; Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg
Active Comparator: Telmisartan 80mg	Drug: Telmisartan 80mg; Telmisartan 80mg monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Sitting Diastolic Blood Pressure (MSDBP)	After 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg	After 4 weeks and 8 weeks of treatment
Control rate	Reduction SBP < 140mmHg, DBP < 90mmHg	After 4 weeks and 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: August 30, 2011
• First Posted (Estimate): August 31, 2011

Study Record Updates

• Last Update Posted (Estimate): September 13, 2012
• Last Update Submitted That Met QC Criteria: September 11, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Telmisartan; Amlodipine; Primary Hypertension; CKD-828; S-Amlodipine; Non-Responder
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 130HT11B