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

NCT00454662 | Completed Phase 4 DMC

• 2 other identifiers: 31-JAN-2007COLM001
• Study Type: interventional
• Target: 5,141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Cardiovascular Disease; Diabetes

Keywords

Elderly; Hypertension; Cardiovascular Diseases; Angiotensin II Type 1 Receptor Blockers; Calcium Channel Blockers; Diuretics; Combination Drug Therapy; Diabetes

Outcome Measures

Primary Outcomes (1)

• Composite of following events: Sudden death, Cerebrovascular events, Coronary events, Renal dysfunction

  3 to 4.5 years (duration of planned treatment phase)

Secondary Outcomes (1)

• All deaths, Death from cardiovascular events, Glucose metabolism, Incidence of primary outcomes events, New onset of atrial fibrillation, Safety, Withdrawal rate

  3 to 4.5 years (duration of planned treatment phase)

Study Arms (2)

1

ACTIVE COMPARATOR

olmesartan medoxomil, Calcium channel blockers (amlodipine, azelnidipine)

Drug: olmesartan medoxomil / amlodipine or azelnidipine

2

ACTIVE COMPARATOR

AT1 subtype angiotensin II receptor antagonist/low dose diuretic

Drug: olmesartan medoxomil / low dose thiazide type drug

Interventions

olmesartan medoxomil / amlodipine or azelnidipine DRUG

AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine

1

olmesartan medoxomil / low dose thiazide type drug DRUG

AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug

2

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• COLM Study Research Organization: lead
• Japan Heart Foundation: collaborator

Study Sites (1)

COLM-Study Data Center

Kamiyacho Mount Bld.14F, 4-3-20 Toranomon Minato-ku, Tokyo, 105-0001, Japan

Location

Related Publications (1)

• Rakugi H, Ogihara T, Saruta T, Kawai T, Saito I, Teramukai S, Shimada K, Katayama S, Higaki J, Odawara M, Tanahashi N, Kimura G; COLM Investigators. Preferable effects of olmesartan/calcium channel blocker to olmesartan/diuretic on blood pressure variability in very elderly hypertension: COLM study subanalysis. J Hypertens. 2015 Oct;33(10):2165-72. doi: 10.1097/HJH.0000000000000668.

  PMID: 26066644 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Diabetes Mellitus

Interventions

Olmesartan Medoxomil; Amlodipine; azelnidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines

Study Officials

• Toshio Ogihara, MD

  Emeritus Professor Osaka University

  STUDY CHAIR

• Takao Saruta, MD

  Emeritus Professor Keio University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 30, 2007
• First Posted: April 2, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

JP (1)