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

• ClinicalTrials.gov Identifier: NCT00891267
• Recruitment Status: Completed
• First Posted: May 1, 2009
• Last Update Posted: December 24, 2018
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Information provided by: Daiichi Sankyo, Inc.

Tracking Information

• First Submitted Date: April 29, 2009
• First Posted Date: May 1, 2009
• Last Update Posted Date: December 24, 2018
• Study Start Date: October 2008
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 30, 2009): 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 [ Time Frame: 6 weeks for each treatment ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00891267 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: April 30, 2009): 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) [ Time Frame: 6 weeks for each treatment ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
• Official Title: Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Metabolic Syndrome
• Hypertension

Intervention

• Drug: Olmesartan medoxomil tablets low dose
  Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
• Drug: Olmesartan medoxomil tablets high dose
  Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
• Drug: Amlodipine
  Amlodipine tablets taken once daily for 6 weeks

Study Arms

• Experimental: Olmesartan medoxomil low dose
  Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
  Intervention: Drug: Olmesartan medoxomil tablets low dose
• Experimental: Olmesartan medoxomil tablets high dose
  Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
  Intervention: Drug: Olmesartan medoxomil tablets high dose
• Active Comparator: Amlodipine
  Amlodipine taken once daily for 6 weeks
  Intervention: Drug: Amlodipine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 30, 2009): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00891267
• Other Study ID Numbers: DSE-866/46; 2007-003130-41 EudraCT number
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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.
• URL: https://vivli.org/ourmember/daiichi-sankyo/

• Responsible Party: Senior Manager Clinical Development, Daiichi Sankyo Europe
• Study Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Daiichi Sankyo, Inc.
• Verification Date: May 2011