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CompletedNCT00454662Updated Jan 23, 2013

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

A Phase 4 interventional study of olmesartan medoxomil / amlodipine or azelnidipine and olmesartan medoxomil / low dose thiazide type drug in Hypertension, Cardiovascular Disease and Diabetes, sponsored by COLM Study Research Organization. Completed at 1 site in Japan. Open to participants aged 65 Years to 84 Years. Per ClinicalTrials.gov, last updated 2013-01-23.

Sponsored by COLM Study Research Organization · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
5,141
Allocation
Randomized
Ages
65 Years to 84 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hypertension
  • Cardiovascular Disease
  • Diabetes

Keywords

  • Elderly
  • Hypertension
  • Cardiovascular Diseases
  • Angiotensin II Type 1 Receptor Blockers
  • Calcium Channel Blockers
  • Diuretics
  • Combination Drug Therapy
  • Diabetes
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 5,141 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

This is the only study on the registry with COLM Study Research Organization as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
5,141 participants (actual)

Study arms

  • Active comparator
    1

    olmesartan medoxomil, Calcium channel blockers (amlodipine, azelnidipine)

    Drug: olmesartan medoxomil / amlodipine or azelnidipine

  • Active comparator
    2

    AT1 subtype angiotensin II receptor antagonist/low dose diuretic

    Drug: olmesartan medoxomil / low dose thiazide type drug

Interventions

  • Drugolmesartan 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

  • Drugolmesartan 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

06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: 3 to 4.5 years (duration of planned treatment phase)

07

Study locations

1 site
  • COLM-Study Data Center
    Kamiyacho MT Bld.14F, 4-3-20 Toranomon Minato-ku, Tokyo 105-0001, Japan
08

References and documents

Publications

  • 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. PubMed 26066644 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00454662
Lead sponsor
COLM Study Research Organization
Collaborators
Japan Heart Foundation
Responsible party
Sponsor
First posted
Apr 2, 2007
Start date
Apr 2007
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jan 23, 2013

Study contacts

Toshio Ogihara, MD
study chair · Emeritus Professor Osaka University
Takao Saruta, MD
study chair · Emeritus Professor Keio University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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