Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01819220
First received: March 15, 2013
Last updated: March 24, 2013
Last verified: March 2013
  Purpose

Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium channel blockers are not well defined. This study will compare the efficacy of RAS inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing 2hour post prandial glucose compared to RAS inhibitors/diuretics.


Condition Intervention Phase
Hypertension
Drug: amlodipine/valsartan
Drug: hydrochlorothiazide/telmisartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • To assess the glucose change [ Time Frame: To assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amlodipine/valsartan Drug: amlodipine/valsartan

This is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome.

Active group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.

When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.

Other Name: Starting dose of amlodipine 5mg/ valsartan 80mg
Experimental: hydrochlorothiazide/telmisartan Drug: hydrochlorothiazide/telmisartan

When the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.

When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.

Other Name: Telmisartan 40mg/hydrochlorothiazide 12.5mg

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • consent to the study
  • Male or Female ≥ 20 years
  • Patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. Hypertension defined at the screening visit as follows): 140mmHg < MSSBP or MSDBP > 90mmHg at screening
  • Hypertensive patients with non diabetic metabolic syndrome will be enrolled. Metabolic syndrome is defined according to NCEP guideline. (3 or more than) ① Abdominal obesity: Waist circumference M ≥ 90cm, F ≥ 80cm

    ② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL

    ③ Low HDL cholesterol Men: HDL cholesterol ≤ 40mg/dL Women: HDL cholesterol ≤ 50mg/dL

    ④ Elevated blood pressure (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 85 mmHg, or current use of antihypertensive drugs)

    ⑤ Impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dL

  • Patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months.

Exclusion Criteria:

  • • Women of child-bearing potential without a contraceptive measure

    • (Pregnant or nursing women
    • Known or suspected contraindications: history of allergy or hypersensitivity
    • History of clinically significant allergies including asthma and/or multiple drug allergies
    • Patients taking more than 2 antihypertensive medications
    • Patient taking statin medication and taking statin within 3 months
    • MSSBP > 180 mmHg or MSDBP > 110 mmHg at any time during the study
    • Evidence of a secondary form of hypertension)
    • History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) for 12 months prior to Visit 1
    • History of heart failure Grade II - IV according to the NYHA classification
    • Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
    • Concomitant unstable angina pectoris
    • Clinically significant valvular heart disease
    • Patients with Type 1 or Type 2 diabetes mellitus
    • Evidence of hepatic disease as determined by one of the following: AST or ALT values ≥ 3 x UNL, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt
    • Evidence of renal impairment as determined by one of the following: serum creatinine >2mg/dL , history of dialysis, or history of nephrotic syndrome
    • Protein in U/A values 2+ ≤
    • Serum potassium values < 3.2 or > 5.2 mmol/L
    • History of malignancy of any organ system within the past 5 years, treated or untreated, including leukemia and lymphoma, as further defined in the full protocol
    • Chronic use of NSAIDs
    • Use of cyclooxygenase-2 inhibitors (COX-2 inhibitors
    • Use of niacin > 100 mg/d
    • Use of loop diuretics
    • Use of statin shorter than 3 months
    • Inability to discontinue prior antihypertensive drugs as specified in the full protocol
    • persons directly involved in the execution of this protocol
    • Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values
    • Any severe, life-threatening disease within the past five years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819220

Contacts
Contact: Sungha Park, MD 82-2-2228-8455 SHPARK0530@yuhs.ac.kr

Locations
Korea, Republic of
Yonsei universty medical center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sungha Park, MD         
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01819220     History of Changes
Other Study ID Numbers: 4-2009-0077
Study First Received: March 15, 2013
Last Updated: March 24, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Telmisartan
Amlodipine, valsartan drug combination
Amlodipine
Hydrochlorothiazide
Telmisartan, hydrochlorothiazide drug combination
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014