NCT00185185

Brief Summary

This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 14, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2005

Last Update Submit

December 12, 2007

Conditions

Essential HypertensionAtherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change of intima media thickness of the common carotid artery on the leading side of the neck.

Secondary Outcomes (4)

  • -Change in plaque volume in the common carotid artery or the carotid bulb.

  • -Change of intima media thickness of the common carotid artery.

  • -Changes of diastolic and systolic blood pressure.

  • -Safety and tolerability

Study Arms (2)

1

EXPERIMENTAL

olmesartan medoxomil

Drug: Olmesartan medoxomilDrug: Hydrochlorothiazide

2

ACTIVE COMPARATOR

atenolol

Drug: AtenololDrug: Hydrochlorothiazide

Interventions

olmesartan medoxomilDRUG
1
atenololDRUG
2
HydrochlorothiazideDRUG

tablets

12

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg
  • Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA
  • Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl

You may not qualify if:

  • Body mass index \> 30
  • Any type of known secondary hypertension
  • Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (\< 50/min)
  • Obstructive pulmonary disease
  • Claudicatio intermittens
  • History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial
  • Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy
  • Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening
  • Treatment with disallowed medication
  • Pregnant or breastfeeding females or females of childbearing potential without adequate contraception
  • History of alcohol and/or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Munich, Germany

Location

Related Publications (1)

  • Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.

    PMID: 37565307DERIVED

MeSH Terms

Conditions

Essential HypertensionAtherosclerosis

Interventions

Olmesartan MedoxomilAtenololHydrochlorothiazide

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Prof. Klaus O Stumpe, MD

    Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

November 1, 2001

Study Completion

February 1, 2006

Last Updated

December 14, 2007

Record last verified: 2007-12

Locations

DE(1)