The Confirmatory Olmesartan Plaque Regression Study

NCT01132768 | Terminated Phase 4

• 1 other identifier: DSE-OLM-01-09
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of olmesartan medoxomil (20-40 mg) on plaque regression in hypertensive patients with carotid atherosclerosis.

Conditions

Essential Hypertension; Carotid Plaque

Outcome Measures

Primary Outcomes (1)

• Change in carotid plaque volume

  change in carotid plaque volume (PV) from baseline (week 0) as assessed by 3-D ultrasonography after 78 weeks of double-blind treatment with Olmesartan (OM) 20-40 mg daily compared to Atenololo (ATE) 50-100 mg daily (week 78 - week 0).

  78 weeks (week 78 - week 0)

Secondary Outcomes (11)

• Change in plaque volume after 52 weeks, olmesartan versus atenolol

  52 weeks (week 52 - week 0)

• Percentage changes of PV from baseline to Week 52 for olmesartan versus atenolol.

  52 weeks (week 52-week 0)

• Percentage changes of PV from baseline to Week 78 for olmesartan versus atenolol.

  78 weeks (week 78 - week 0)

• Change in seated diastolic blood pressure (SeDBP) from baseline to Week 52 for olmesartan versus atenolol.

  52 weeks (week 52 - week 0)

• Change in seated diastolic blood pressure (SeDBP) from baseline to Week 78 for olmesartan versus atenolol.

  78 weeks (week 78 - week 0)

Study Arms (2)

Atenolol

ACTIVE COMPARATOR

Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily.

Drug: Atenolol

Olmesartan medoxomil

EXPERIMENTAL

Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily.

Drug: olmesartan medoxomil

Interventions

Atenolol DRUG

Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily

Atenolol

olmesartan medoxomil DRUG

Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily

Olmesartan medoxomil

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female Caucasian outpatients aged \> 40 years.
• High BP defined as mean SeSBP/SeDBP ≥ 140/90 mmHg.
• One or more of the following additional risk factors:
• Smoking;
• Dyslipidaemia (high-density lipoprotein (HDL)-cholesterol \< 0.9 mmol/L or low-density lipoprotein (LDL)-cholesterol \> 2.6 mmol/L, or triglycerides \> 1.7 mmol/L);
• Left ventricular hypertrophy;
• Cardio-cerebrovascular events \> 6 months ago;
• Presence of target organ damage.
• Non-calcified (not marked shadowing) plaque in the CC artery, in the internal carotid artery or the carotid bulb with a PV ≥ 0.040 cm³ (≥ 40 µL) according to the measurements of EUTARC.

You may not qualify if:

• Secondary or high grade hypertension including grade III hypertension (SeSBP of \> 180 mmHg or SeDBP of \> 105 mmHg).
• Stroke, myocardial infarction within the previous 6 months.
• Interventional or surgical vascular treatment within the previous 3 months.
• Presence of significant narrowing of the aortic or bicuspid valve and severe obstruction of cardiac outflow (hypertrophic cardiomyopathy).
• Symptomatic heart failure.
• Diabetes.
• Chronic obstructive pulmonary disease (COPD) or asthma.
• Claudication intermittens stage II b or higher.
• Clinical evidence of severe renal disease \[including renovascular occlusive disease, nephrectomy and/or renal transplant, creatinine clearance of \< 30 mL/min, macroalbuminuria (\> 300 mg albumin/24 hours or 300 µg albumin/mg creatinine)\].
• Treatment with angiotensin converting enzyme (ACE)-inhibitors or angiotensin-receptor blockers (ARBs) during last 3 months.
• Start of treatment with a lipid-lowering agent or modification of dosage within last 3 months.
• Electrocardiographic (ECG) evidence of 2nd or 3rd degree atrioventricular (AV) block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia (\< 50 beats/min at rest).
• Known intolerance to study drugs.
• Impaired liver function tests suggesting severe liver disorder.
• Any life threatening disease.

Sponsors & Collaborators

• Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company: lead

Study Sites (1)

Unknown Facility

Sesto Fiorentino, 50019, Italy

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Atenolol; Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Klaus O Stumpe, MD

  Centre of Preventative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 24, 2018

Record last verified: 2012-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

IT (1)