Who is sponsoring NCT00454662?

NCT00454662 is sponsored by COLM Study Research Organization.

What drugs are being tested in NCT00454662?

Interventions in NCT00454662: olmesartan medoxomil / amlodipine or azelnidipine, olmesartan medoxomil / low dose thiazide type drug.

What condition does NCT00454662 study?

NCT00454662 studies Hypertension, Cardiovascular Disease, Diabetes.

Is NCT00454662 still recruiting?

NCT00454662 is currently completed. Last updated 22 January 2013.

Last reviewed 2013-01-22 · How we verify

NCT00454662

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 22 January 2013

What this trial tests

Phase 4 trial testing olmesartan medoxomil / amlodipine or azelnidipine in Hypertension in 5,141 participants. Completed in 1 September 2011.

Timeline

1 April 2007

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	COLM Study Research Organization
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	5,141
Start date	1 April 2007
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	1 location across Japan

Drugs / interventions tested

olmesartan medoxomil / amlodipine or azelnidipine — full drug profile →
olmesartan medoxomil / low dose thiazide type drug — full drug profile →

Conditions studied

Hypertension — all drugs for Hypertension →
Cardiovascular Disease — all drugs for Cardiovascular Disease →
Diabetes — all drugs for Diabetes →

Sponsor

COLM Study Research Organization — full company profile →

Who can join

Adults 65 to 84, any sex, with Hypertension or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Preferable effects of olmesartan/calcium channel blocker to olmesartan/diuretic on blood pressure variability in very elderly hypertension: COLM study subanalysis.
Rakugi H, Ogihara T, Saruta T, Kawai T, et al · · 2015 · cited 22× · PMID 26066644 · DOI 10.1097/hjh.0000000000000668

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00454662 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by COLM Study Research Organization
Last refreshed: 22 January 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00454662.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing