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Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Eprosartan (Drug); Eprosartan Mesylate (Drug); Placebo Eprosartan mesylate (Drug); Placebo Eprosartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Dmitri N. Kazei, MD, Study Director, Affiliation: Abbott Healthcare Products B.V.

Summary

Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

Clinical Details

Official title: A Prospective, Randomized Double-blind Parallel Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects With Mild to Moderate Essential Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Males or females with essential hypertension, blood pressure values between 140 mmHg

and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic

- Given written informed consent prior to starting the study

Exclusion Criteria

- Women with childbearing potential, breast feeding or pregnant;

- Inability to discontinue all prior antihypertensive medication;

- Secondary hypertension

- Severe hypertension

- Severe diabetes mellitus (HbA1c greater 8. 5%)

Locations and Contacts

Site Reference ID/Investigator# 74062, Berlin 12627, Germany

Site Reference ID/Investigator# 74066, Bochum 44787, Germany

Site Reference ID/Investigator# 74065, Dresden 01067, Germany

Site Reference ID/Investigator# 93513, Dresden 01307, Germany

Site Reference ID/Investigator# 93495, Essen 45355, Germany

Site Reference ID/Investigator# 74060, Frankfurt 60596, Germany

Site Reference ID/Investigator# 93515, Frankfurt 60594, Germany

Site Reference ID/Investigator# 74063, Goerlitz 02826, Germany

Site Reference ID/Investigator# 93494, Hamburg 22143, Germany

Site Reference ID/Investigator# 93493, Karlsruhe 76199, Germany

Site Reference ID/Investigator# 74061, Leipzig 04103, Germany

Site Reference ID/Investigator# 74064, Magdeburg 39104, Germany

Site Reference ID/Investigator# 93514, Nuremberg 90402, Germany

Site reference ID/Investigator # 82515, Barnaul 656055, Russian Federation

Site reference ID/Investigator # 82520, Kazan 420012, Russian Federation

Site reference ID/Investigator # 82493, Kemerovo 650002, Russian Federation

Site reference ID/Investigator # 82516, Kemerovo 650055, Russian Federation

Site refernce ID/Investigator # 82521, Krasnodar 350086, Russian Federation

Site reference ID/Investigator # 82494, Novosibirsk 630047, Russian Federation

Site reference ID/Investigator # 82495, Novosibirsk 630008, Russian Federation

Site reference ID/Investigator # 82525, Novosibirsk 630068, Russian Federation

Site reference ID/Investigator # 82517, St. Petersburg 194044, Russian Federation

Site reference ID/Investigator # 82518, St. Petersburg 198260, Russian Federation

Site reference ID/Investigator # 82519, St. Petersburg 198205, Russian Federation

Site reference ID/Investigator # 82522, St. Petersburg 192283, Russian Federation

Site reference ID/Investigator # 82524, St. Petersburg 197022, Russian Federation

Site reference ID/Investigator # 82527, St. Petersburg 199106, Russian Federation

Site reference ID/Investiragor # 82523, St. Petersburg 197022, Russian Federation

Site Reference ID/Investigator# 74057, Birmingham B15 2SQ, United Kingdom

Site Reference ID/Investigator# 74059, Cardiff CF14 5GJ, United Kingdom

Site Reference ID/Investigator# 74056, Chorley PR7 7NA, United Kingdom

Site reference ID/Investigator # 95456, Glasgow G45 9AW, United Kingdom

Site Reference ID/Investigator# 74054, Glasgow G20 0SP, United Kingdom

Site Reference ID/Investigator# 74053, Liverpool L22 0LG, United Kingdom

Site reference ID/Investigator # 95457, London EC1M 6BQ, United Kingdom

Site Reference ID/Investigator# 74055, Manchester M16 6SX, United Kingdom

Site reference ID/Investigator # 95455, Northwood HA6 2RN, United Kingdom

Site Reference ID/Investigator# 74058, Reading RG2 0TG, United Kingdom

Additional Information

Starting date: June 2012
Last updated: July 18, 2014

Page last updated: August 23, 2015

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