Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

NCT00891267 | Completed Phase 3

• 2 other identifiers: DSE-866/462007-003130-41 EudraCT number
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.

Conditions

Metabolic Syndrome; Hypertension

Keywords

Inflammatory markers; Vascular protection; OM Effect; Metabolic syndrome; Hypertension

Outcome Measures

Primary Outcomes (1)

• To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP

  6 weeks for each treatment

Secondary Outcomes (1)

• To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM)

  6 weeks for each treatment

Study Arms (3)

Olmesartan medoxomil low dose

EXPERIMENTAL

Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks

Drug: Olmesartan medoxomil tablets low dose

Olmesartan medoxomil tablets high dose

EXPERIMENTAL

Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks

Drug: Olmesartan medoxomil tablets high dose

Amlodipine

ACTIVE COMPARATOR

Amlodipine taken once daily for 6 weeks

Drug: Amlodipine

Interventions

Olmesartan medoxomil tablets low dose DRUG

Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks

Olmesartan medoxomil low dose

Olmesartan medoxomil tablets high dose DRUG

Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks

Olmesartan medoxomil tablets high dose

Amlodipine DRUG

Amlodipine tablets taken once daily for 6 weeks

Amlodipine

Eligibility Criteria

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

You may qualify if:

• Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
• Blood pressure greater than or equal to 130/85 mmHg AND
• hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
• abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
• triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
• fasting blood glucose greater than or equal to 110mg/dL

You may not qualify if:

• Insulin depended diabetes or type-1 diabetes
• Severe or resistant hypertension
• Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
• Any acute or chronic inflammatory disease
• Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
• Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
• Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Erlangen, Germany

Location

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension

Interventions

Olmesartan Medoxomil; Amlodipine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 1, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 24, 2018

Record last verified: 2011-05

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

DE (1)