Back to results

Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TELMINUVO Tab. (80/2.5mg)

TELMINUVO Tab. (80/5mg)

S-amlodipine 2.5mg

S-amlodipine 5mg

About this trial

This is an interventional treatment trial for Hypertension focused on measuring TELMINUVO Tab., CKD-828, Hypertension, Stage 2 Hypertension, S-Amlodipine, Telmisartan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The catholic university of Korea Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TELMINUVO Tab. (80/2.5mg, 80/5mg)

S-Amlodipine 2.5, 5mg

Arm Description

Outcomes

Primary Outcome Measures

Mean Sitting Systolic Blood Pressure (MSSBP)

Secondary Outcome Measures

Mean Sitting Systolic Blood Pressure (MSSBP)

Mean Sitting Diastolic Blood Pressure (MSDBP)

Control Rate

Sitting SBP<140mmHg, Sitting DBP<90mmHg

Response Rate

Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg

Full Information

NCT ID

NCT01983735

First Posted

November 7, 2013

Last Updated

November 7, 2013

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01983735

Brief Title

Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

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(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

TELMINUVO Tab., CKD-828, Hypertension, Stage 2 Hypertension, S-Amlodipine, Telmisartan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TELMINUVO Tab. (80/2.5mg, 80/5mg)

Arm Type

Experimental

Arm Title

S-Amlodipine 2.5, 5mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

TELMINUVO Tab. (80/2.5mg)

Other Intervention Name(s)

TELMINUVO Tab.

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

TELMINUVO Tab. (80/5mg)

Other Intervention Name(s)

TELMINUVO Tab.

Intervention Description

Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks. With the others investigation product placebo 1 tab QD 6 weeks.

Intervention Type

Drug

Intervention Name(s)

S-amlodipine 2.5mg

Other Intervention Name(s)

Anydipine S

Intervention Description

S-amlodipine 2.5mg QD 2 weeks With the others investigation product placebo 1 tab QD 2 weeks.

Intervention Type

Drug

Intervention Name(s)

S-amlodipine 5mg

Other Intervention Name(s)

Anydipine S

Intervention Description

S-amlodipine 5mg QD 6weeks With the others investigation product placebo 1 tab QD 6 weeks.

Primary Outcome Measure Information:

Title

Mean Sitting Systolic Blood Pressure (MSSBP)

Time Frame

After 8 weeks of treatment

Secondary Outcome Measure Information:

Title

Mean Sitting Systolic Blood Pressure (MSSBP)

Time Frame

After 2 weeks and 4 weeks of treatment

Title

Mean Sitting Diastolic Blood Pressure (MSDBP)

Time Frame

After 2weeks, 4weeks and 8 weeks of treatment

Title

Control Rate

Description

Sitting SBP<140mmHg, Sitting DBP<90mmHg

Time Frame

After 8 weeks of treatment

Title

Response Rate

Description

Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg

Time Frame

After 8 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ho-Joong Yoon, Ph.D

Phone

82-2-2258-6029

younhj@catholic.ac.kr

Facility Information:

Facility Name

The catholic university of Korea Seoul St. Mary's hospital

City

Seoul

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ho-Joong Yoon, Ph.D

Phone

82-2-2258-6029

younhj@catholic.ac.kr

First Name & Middle Initial & Last Name & Degree

Ho-Joong Yoon, Ph.D

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

We'll reach out to this number within 24 hrs