HypertensionPhase 4NCT00454662

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

A Phase 4 study testing olmesartan medoxomil / amlodipine or azelnidipine and olmesartan medoxomil / low dose thiazide type drug in people with Hypertension and Cardiovascular Disease, run by COLM Study Research Organization at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 65 to 84 years
Conditions the study is for: Hypertension, Cardiovascular Disease, Diabetes
What is being tested?: olmesartan medoxomil / amlodipine or azelnidipine and olmesartan medoxomil / low dose thiazide type drug
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,141 participants
Where: 1 siteJapan
Study dates: Apr 2007to Sep 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 84 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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）

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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)

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

Japan1 site

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

Other trials in Japan

About this study

Official title: Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)

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

Conditions: Hypertension, Cardiovascular Disease, Diabetes
Being tested: olmesartan medoxomil / amlodipine or azelnidipine, olmesartan medoxomil / low dose thiazide type drug
Keywords: Elderly, Hypertension, Cardiovascular Diseases, Angiotensin II Type 1 Receptor Blockers, Calcium Channel Blockers, Diuretics, Combination Drug Therapy, Diabetes
Medical subject headings: Hypertension, Cardiovascular Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

olmesartan medoxomil / amlodipine or azelnidipineDrug
AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine
olmesartan medoxomil / low dose thiazide type drugDrug
AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug

Study groups in NCT00454662
Study group	Role	What they receive
1	Active comparator	olmesartan medoxomil, Calcium channel blockers (amlodipine, azelnidipine) Receives: Drug: olmesartan medoxomil / amlodipine or azelnidipine
2	Active comparator	AT1 subtype angiotensin II receptor antagonist/low dose diuretic Receives: Drug: olmesartan medoxomil / low dose thiazide type drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of following events: Sudden death, Cerebrovascular events, Coronary events, Renal dysfunction
Measured: 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
Measured: 3 to 4.5 years (duration of planned treatment phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Sep 2011

First posted2 Apr 2007 (estimated)
Study startApr 2007
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 5,141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00454662
Sponsor's protocol ID: 31-JAN-2007
Other IDs: COLM001
Status last verified: Jan 2013
First submitted: 30 Mar 2007
Last updated: 23 Jan 2013
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)
ClinicalTrials.gov ID: NCT00454662
Acronym / sponsor ID: 31-JAN-2007
Conditions: Hypertension, Cardiovascular Disease, Diabetes
Keywords: Elderly, Hypertension, Cardiovascular Diseases, Angiotensin II Type 1 Receptor Blockers, Calcium Channel Blockers, Diuretics, Combination Drug Therapy, Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,141 participants (actual)
Lead sponsor: COLM Study Research OrganizationUniversity, hospital or other
Collaborators: Japan Heart Foundation
Study start: Apr 2007
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 2 Apr 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: olmesartan medoxomil / amlodipine or azelnidipineolmesartan medoxomil, Calcium channel blockers (amlodipine, azelnidipine)
2	Active comparator	Drug: olmesartan medoxomil / low dose thiazide type drugAT1 subtype angiotensin II receptor antagonist/low dose diuretic

Who may qualify

Ages: 65 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
olmesartan medoxomil / amlodipine or azelnidipineAT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine	Drug	1
olmesartan medoxomil / low dose thiazide type drugAT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug	Drug	2

Primary outcome

Composite of following events: Sudden death, Cerebrovascular events, Coronary events, Renal dysfunction
Time frame: 3 to 4.5 years (duration of planned treatment phase)

1 secondary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
Derived from this study: PubMed 26066644Rakugi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshio Ogihara, MD study chair

Emeritus Professor Osaka University

Takao Saruta, MD study chair

Emeritus Professor Keio University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of following events: Sudden death, Cerebrovascular events, Coronary events, Renal dysfunction (time frame: 3 to 4.5 years (duration of planned treatment phase)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00454662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.