Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01983735
• Other study ID #: 130HT13015
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 7, 2013
• Last updated: November 7, 2013
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2013
• Source: Chong Kun Dang Pharmaceutical
• Contact: Ho-Joong Yoon, Ph.D
• Phone: 82-2-2258-6029
• Email: younhj[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.
• S-amlodipine 2.5mg
S-amlodipine 2.5mg QD 2 weeks With the others investigation product placebo 1 tab QD 2 weeks.
• S-amlodipine 5mg
S-amlodipine 5mg QD 6weeks With the others investigation product placebo 1 tab QD 6 weeks.

Locations

Country	Name	City	State
Korea, Republic of	The catholic university of Korea Seoul St. Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Sitting Systolic Blood Pressure (MSSBP)		After 8 weeks of treatment	No
Secondary	Mean Sitting Systolic Blood Pressure (MSSBP)		After 2 weeks and 4 weeks of treatment	No
Secondary	Mean Sitting Diastolic Blood Pressure (MSDBP)		After 2weeks, 4weeks and 8 weeks of treatment	No
Secondary	Control Rate	Sitting SBP<140mmHg, Sitting DBP<90mmHg	After 8 weeks of treatment	No
Secondary	Response Rate	Reduction of Sitting SBP=20mmHg, Sitting DBP =10mmHg	After 8 weeks of treatment	No