Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

Chong Kun Dang

Status and phase

Unknown

Phase 3

Conditions

Hypertension

Treatments

Drug: TELMINUVO Tab. (80/2.5mg)

Drug: S-amlodipine 2.5mg

Drug: TELMINUVO Tab. (80/5mg)

Drug: S-amlodipine 5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01983735

130HT13015

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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