Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study) - Full Text View

Sponsors and Collaborators:	COLM Study Research Organization Japan Heart Foundation
Information provided by:	COLM Study Research Organization
ClinicalTrials.gov Identifier:	NCT00454662

Purpose

The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic.

Condition	Intervention	Phase
Hypertension Cardiovascular Disease Diabetes	Drug: olmesartan medoxomil / amlodipine or azelnidipine Drug: olmesartan medoxomil / low dose thiazide type drug	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia Calcium Diabetes High Blood Pressure

Drug Information available for: Angiotensin II Amlodipine Amlodipine besylate Azelnidipine Olmesartan Olmesartan medoxomil Calcium gluconate Angiotensin II, ile(5)-

U.S. FDA Resources

Further study details as provided by COLM Study Research Organization:

Primary Outcome Measures:

Composite of following events: Sudden death, Cerebrovascular events, Coronary events, Renal dysfunction [ Time Frame: 3 to 4.5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All deaths, Death from cardiovascular events, Glucose metabolism, Incidence of primary outcomes events, New onset of atrial fibrillation, Safety, Withdrawal rate [ Time Frame: 3 to 4.5 years (duration of planned treatment phase) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4000
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator olmesartan medoxomil, Calcium channel blockers (amlodipine, azelnidipine)	Drug: olmesartan medoxomil / amlodipine or azelnidipine AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine
2: Active Comparator AT1 subtype angiotensin II receptor antagonist/low dose diuretic	Drug: olmesartan medoxomil / low dose thiazide type drug AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug

Detailed Description:

Recently, antihypertensive combination therapies have been recommended by various guidelines because of their additive effects. Combination therapies of AT1 subtype angiotensin II receptor antagonist and calcium channel blocker or low dose diuretic have shown pharmacological benefit. However, reduction of cardiovascular events and safety profile of these combination therapies under same level of antihypertensive target have not been investigated yet. In this study, primary objective is to compare two combination therapies when antihypertensive target is 140/90mmHg in elderly hypertensive patients with high cardiovascular risk.

Further study details as provided by COLM-Study data center

Primary Outcomes: A composite of fatal and non-fatal cardiovascular events: Sudden death (death of endogenous origin within 24 hours after acute onset); Cerebrovascular events (new occurrence or recurrence of a cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack); Coronary events (new occurrence or recurrence of a myocardial infarction, coronary revascularization[PCI or CABG], hospitalization for angina pectoris, hospitalization for heart failure); Renal dysfunction (doubling of serum creatinine and creatinine ≥2.0 mg/dl, end stage renal disease) Secondary Outcomes: All deaths; Death from cardiovascular events; Effects on glucose metabolism(fasting plasma glucose, postprandial glucose, new onset of diabetes mellitus); Incidence of primary outcomes events; New occurrence of atrial fibrillation; Safety; Proportion of the subjects who withdrew from the allocated treatment

Eligibility

Ages Eligible for Study:	65 Years to 84 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex
Systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications.
Systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication.
Require at least one of the following medical history or risk factors
Medical history
- Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage（6 months or more prior to registration）
- Myocardial infarction, coronary revascularization (PCI or　CABG) （6 months or more prior to registration）
- Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration)
Risk factors
- Male
- Current diabetes mellitus, fasting glucose ≥ 110mg/dL or postprandial glucose ≥ 140mg/dl
- Hypercholesterolemia (Total cholesterol ≥ 260mg/dL)
- Low HDL cholesterolemia (HDL-C ＜40mg/dL)
- Microalbuminuria (albumin/cr ≥ 30mg/gCr) or proteinuria (protein ≥ 1＋)
- Left ventricular hypertrophy (ST-T change in the ECG and SV1＋RV5 ≥ 35mm, or left ventricular mass index:

male ≥ 125 g/m2, female ≥ 110 g/m2)

Exclusion Criteria:

Secondary hypertension or malignant hypertension
History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration
Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled
History of hospitalization for angina pectoris or heart failure within 6 months before registration
Severe heart failure (New York Heart Association [NYHA] functional class III or more severe)
Complications of atrial fibrillation, atrial flutter or severe arrhythmia
Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine ≥ 2.0mg/dL)
Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc)
History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic)
Life threatening condition (malignant tumor, etc)
Not suited to be study subject judged by a study physician

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454662

Locations

Japan, Tokyo
COLM-Study Data Center
Kamiyacho MT Bld.14F, 4-3-20 Toranomon Minato-ku, Tokyo, Japan, 105-0001

Sponsors and Collaborators

COLM Study Research Organization

Japan Heart Foundation

Investigators

Study Chair:	Toshio Ogihara, MD	Emeritus Professor Osaka University
Study Chair:	Takao Saruta, MD	Emeritus Professor Keio University

More Information

Additional Information:

Combination of OLMesartan and calcium channel blocker or low dose diuretics in high risk elderly hypertensive patients study (COLM-Study) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Osaka University Graduate School of Medicine ( Ogihara Toshio )
Study ID Numbers:	31-JAN-2007, COLM001
Study First Received:	March 30, 2007
Last Updated:	November 16, 2008
ClinicalTrials.gov Identifier:	NCT00454662 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by COLM Study Research Organization:

Elderly
Hypertension
Cardiovascular Diseases
Angiotensin II Type 1 Receptor Blockers

Calcium Channel Blockers
Diuretics
Combination Drug Therapy
Diabetes

Study placed in the following topic categories:

Vasodilator Agents
Diuretics
Diabetes Mellitus
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents

Angiotensin II
Antihypertensive Agents
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Vasoconstrictor Agents
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diuretics
Vascular Diseases
Calcium Channel Blockers
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II

Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009