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

NCT01819220 | Completed Phase 4

• 1 other identifier: 4-2009-0077
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• To assess the glucose change

  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)

Study Arms (2)

amlodipine/valsartan

ACTIVE COMPARATOR

Drug: amlodipine/valsartan

hydrochlorothiazide/telmisartan

EXPERIMENTAL

Drug: hydrochlorothiazide/telmisartan

Interventions

amlodipine/valsartan DRUG

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.

Also known as: Starting dose of amlodipine 5mg/ valsartan 80mg

amlodipine/valsartan

hydrochlorothiazide/telmisartan DRUG

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.

Also known as: Telmisartan 40mg/hydrochlorothiazide 12.5mg

hydrochlorothiazide/telmisartan

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei universty medical center

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination; Valsartan; telmisartan, hydrochlorothiazide drug combination; Telmisartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amlodipine; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 27, 2013
• Study Start: April 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

KR (1)