Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

NCT00129233 | Completed Phase 4 DMC

• 1 other identifier: 169
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 1

Brief Summary

Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.

Conditions

Hypertension; Type 2 Diabetes Mellitus

Keywords

cardiovascular disease; rennin-angiotensin system; calcium channel blocker; impaired glucose tolerance

Outcome Measures

Primary Outcomes (1)

• Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death

  At least 3 years of mean follow up period

Secondary Outcomes (5)

• total death

  At least 3 years of mean follow up period

• cardiac function evaluated by ultrasonography

  At least 3 years of mean follow up period

• incidence of atrial fibrillation/flutter

  At least 3 years of mean follow up period

• control of blood glucose

  At least 3 years of mean follow up period

• renal function

  At least 3 years of mean follow up period

Study Arms (2)

Valsartan

ACTIVE COMPARATOR

Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors.

Drug: Valsartan

Amlodipine

ACTIVE COMPARATOR

Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers.

Drug: Amlodipine

Interventions

Valsartan DRUG

valsartan 80 to 160 mg daily

Valsartan

Amlodipine DRUG

Amlodipine 5 to 10 mg daily.

Amlodipine

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of hypertension
• Clinical diagnosis of type 2 diabetes or impaired glucose tolerance

You may not qualify if:

• History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
• Taking calcium channel blocker for the purpose of angina pectoris
• Reduced ejection fraction (\< 40%)
• Second- or third-degree of atrioventricular block
• Severe hypertension (\> 200/110 mmHg) or secondary hypertension
• History of stroke in the recent 6 months
• Serum creatinine \> 2.5 mg/dl
• Estimated survival duration less than 3 years due to other conditions
• Pregnant woman or possibly pregnant woman

Sponsors & Collaborators

• Nagoya University: lead

Study Sites (1)

Department of Cardiology, Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, 466-8550, Japan

Location

Related Publications (4)

• Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. doi: 10.1016/S0140-6736(04)16451-9.

  PMID: 15207952 BACKGROUND

• Yamashita K, Kondo T, Muramatsu T, Matsushita K, Nagahiro T, Maeda K, Shintani S, Murohara T. Effects of valsartan versus amlodipine in diabetic hypertensive patients with or without previous cardiovascular disease. Am J Cardiol. 2013 Dec 1;112(11):1750-6. doi: 10.1016/j.amjcard.2013.07.043. Epub 2013 Sep 13.

  PMID: 24035165 DERIVED

• Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, Ichimiya S, Ohno M, Sone T, Ikeda N, Watarai M, Murohara T; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study. Hypertension. 2012 Mar;59(3):580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226. Epub 2012 Jan 9.

  PMID: 22232134 DERIVED

• Matsushita K, Muramatsu T, Kondo T, Maeda K, Shintani S, Murohara T; NAGOYA HEART Study Group. Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance. J Cardiol. 2010 Jul;56(1):111-7. doi: 10.1016/j.jjcc.2010.03.004. Epub 2010 Apr 20.

  PMID: 20409690 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Glucose Intolerance

Interventions

Valsartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dihydropyridines; Pyridines

Study Officials

• Toyoaki Murohara, MD, PhD

  Department of Cardiology, Nagoya University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: August 10, 2005
• First Posted: August 11, 2005
• Study Start: October 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2013
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

JP (1)