Efficacy and Safety of CKD-828 to Stage 2 Hypertension

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension

The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Study Overview

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

Detailed Description

• In patients with Stage 2 hypertension to determine the efficacy and safety of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 10 weeks.
• This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(10 weeks_double blind.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Bundang-gu, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 18 years or older

• at the screening visit

  • antihypertensive drugs not taking: 160mmHg ≤ sitSBP < 200mmHg
  • antihypertensive drugs taking: 140mmHg ≤ sitSBP < 180mmHg
• at the randomization visit(160mmHg ≤ sitSBP < 200mmHg)
• willing and able to provide written informed consent

Exclusion Criteria:

• mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
• for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
• 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), ischaemic heart diseasesstatus need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
• 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%)
• known severe or malignant retinopathy

• defined by the following laboratory parameters:

  • hepatic dysfunction(AST/ALT > UNL X 3)
  • renal dysfunction(serum creatinine > UNL X 1.5)
  • hypopotassemia(K < 3.0mmol/L) or hyperpotassemia (K>5.5 mmol/L)
• 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 4weeks 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-828 2.5/40, 2.5/80, 5/80mg	Drug: CKD-828 2.5/40mg; Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks.; With the others investigation product placebo 4 tabs QD 2 weeks.; Other Names: CKD-828; Drug: CKD-828 5/40mg; Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks.; With the others investigation product placebo 4 tabs QD 2 weeks.; Other Names: CKD-828; Drug: CKD-828 5/80mg; Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks.; With the others investigation product placebo 4 tabs QD 6 weeks.; Other Names: CKD-828
Active Comparator: S-Amlodipine 2.5, 5mg	Drug: S-amlodipine 2.5mg; S-amlodipine 2.5mg QD 4 weeks; With the others investigation product placebo 4 tabs QD 4 weeks.; Other Names: Anydipine S; Drug: S-amlodipine 5mg; S-amlodipine 2.5mg QD 6weeks; With the others investigation product placebo 4 tabs QD 6 weeks.; Other Names: Anydipine S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Sitting systolic Blood Pressure (MSSBP)	After 10 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Sitting systolic Blood Pressure (MSSBP)		After 2 weeks, 4 weeks and 6 weeks of treatment
Mean Sitting diastolic Blood Pressure (MSDBP)		After 2weeks, 4weeks, 6weeks and 10 weeks of treatment
Control Rate	Sitting SBP<140mmHg, Sitting DBP<90mmHg	After 10 weeks of treatment
Response Rate	Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg	After 10 weeks of treatment

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Tae-hoon An, Ph.D, Gachon University Gil Medical Center; Principal Investigator: Eun-joo Jo, Ph.D, The Catholic university of Korea St. Paul's Hospitial; Principal Investigator: Jong-jin Kim, Ph.D, Kyung Hee university Hosipital at Gangdong; Principal Investigator: Jang-ho Bae, Ph.D, Konyang University Hosipital; Principal Investigator: Chang-kyu Park, Ph.D, Korea University Guro Hospital; Principal Investigator: Young-dae Kim, Ph.D, Dong-A University; Study Chair: Chul-ho Kim, Ph.D, Seoul National University Bundang Hospital; Principal Investigator: Sae-Joong Lim, Ph.D, Gangnam Severance Hospital; Principal Investigator: Uk-Bum Phyun, Ph.D, Ewha Women University Mokdong Hospital; Principal Investigator: Gyu-Rok Han, Ph.D, Kangdong Sacred Heart Hospital; Principal Investigator: Sang Hyun Kim, Ph.D, Seoul National University Boramae Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Hypertension; Telmisartan; CKD-828; S-Amlodipine; Stage 2 Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Membrane Transport Modulators; Vitamins; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Vitamin B Complex; Amlodipine; Niacin
• Other Study ID Numbers: 130HT11P