Efficacy and Safety of TELMINUVO 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 Telmisartan and S-Amlodipine(TELMINUVO TAB.) 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 Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: TELMINUVO Tab. (80/2.5mg); Drug: TELMINUVO Tab. (80/5mg); Drug: S-amlodipine 2.5mg; Drug: S-amlodipine 5mg

Detailed Description

• In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks.
• This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(8 weeks_double blind).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary'S 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

• 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 diseases status 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 screening
• 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
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TELMINUVO Tab. (80/2.5mg, 80/5mg)	Drug: TELMINUVO Tab. (80/2.5mg); Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks.; With the others investigation product placebo 1 tab QD 2 weeks.; Other Names: TELMINUVO Tab.; Drug: TELMINUVO Tab. (80/5mg); Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks.; With the others investigation product placebo 1 tab QD 6 weeks.; Other Names: TELMINUVO Tab.
ACTIVE_COMPARATOR: S-Amlodipine 2.5, 5mg	Drug: S-amlodipine 2.5mg; S-amlodipine 2.5mg QD 2 weeks; With the others investigation product placebo 1 tab QD 2 weeks.; Other Names: Anydipine S; Drug: S-amlodipine 5mg; S-amlodipine 5mg QD 6weeks; With the others investigation product placebo 1 tab 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 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Sitting Systolic Blood Pressure (MSSBP)		After 2 weeks and 4 weeks of treatment
Mean Sitting Diastolic Blood Pressure (MSDBP)		After 2weeks, 4weeks and 8 weeks of treatment
Control Rate	Sitting SBP<140mmHg, Sitting DBP<90mmHg	After 8 weeks of treatment
Response Rate	Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg	After 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2014
• Study Completion (ANTICIPATED): August 1, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (ESTIMATE): November 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 7, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Hypertension; Telmisartan; CKD-828; S-Amlodipine; Stage 2 Hypertension; TELMINUVO Tab.
• 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: 130HT13015