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

Sponsors

Lead Sponsor: Chong Kun Dang Pharmaceutical

Source Chong Kun Dang Pharmaceutical
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).

Overall Status Unknown status
Start Date January 2014
Completion Date August 2014
Primary Completion Date August 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Sitting Systolic Blood Pressure (MSSBP) After 8 weeks of treatment
Secondary Outcome
Measure 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 After 8 weeks of treatment
Response Rate After 8 weeks of treatment
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: TELMINUVO Tab. (80/2.5mg)

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.

Arm Group Label: TELMINUVO Tab. (80/2.5mg, 80/5mg)

Other Name: TELMINUVO Tab.

Intervention Type: Drug

Intervention Name: TELMINUVO Tab. (80/5mg)

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.

Arm Group Label: TELMINUVO Tab. (80/2.5mg, 80/5mg)

Other Name: TELMINUVO Tab.

Intervention Type: Drug

Intervention Name: S-amlodipine 2.5mg

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

Arm Group Label: S-Amlodipine 2.5, 5mg

Other Name: Anydipine S

Intervention Type: Drug

Intervention Name: S-amlodipine 5mg

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

Arm Group Label: S-Amlodipine 2.5, 5mg

Other Name: Anydipine S

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Ho-Joong Yoon, Ph.D

Phone: 82-2-2258-6029

Email: [email protected]

Location
Facility: Contact: Investigator: The catholic university of Korea Seoul St. Mary's hospital Ho-Joong Yoon, Ph.D 82-2-2258-6029 [email protected] Ho-Joong Yoon, Ph.D Principal Investigator
Location Countries

Korea, Republic of

Verification Date

November 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

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

Type: Experimental

Label: S-Amlodipine 2.5, 5mg

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov