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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631227
• Other study ID #: M13-385
• Secondary ID: 2010-019432-12
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2012
• Last updated: July 18, 2014
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2014
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%)

Study Design

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Eprosartan
Eprosartan 450 mg
• Eprosartan Mesylate
Eprosartan mesylate 600 mg
• Placebo Eprosartan mesylate
Placebo Eprosartan mesylate
• Placebo Eprosartan
Placebo Eprosartan

Locations

Country	Name	City	State
Germany	Site Reference ID/Investigator# 74062	Berlin
Germany	Site Reference ID/Investigator# 74066	Bochum
Germany	Site Reference ID/Investigator# 74065	Dresden
Germany	Site Reference ID/Investigator# 93513	Dresden
Germany	Site Reference ID/Investigator# 93495	Essen
Germany	Site Reference ID/Investigator# 74060	Frankfurt
Germany	Site Reference ID/Investigator# 93515	Frankfurt
Germany	Site Reference ID/Investigator# 74063	Goerlitz
Germany	Site Reference ID/Investigator# 93494	Hamburg
Germany	Site Reference ID/Investigator# 93493	Karlsruhe
Germany	Site Reference ID/Investigator# 74061	Leipzig
Germany	Site Reference ID/Investigator# 74064	Magdeburg
Germany	Site Reference ID/Investigator# 93514	Nuremberg
Russian Federation	Site reference ID/Investigator # 82515	Barnaul
Russian Federation	Site reference ID/Investigator # 82520	Kazan
Russian Federation	Site reference ID/Investigator # 82493	Kemerovo
Russian Federation	Site reference ID/Investigator # 82516	Kemerovo
Russian Federation	Site refernce ID/Investigator # 82521	Krasnodar
Russian Federation	Site reference ID/Investigator # 82494	Novosibirsk
Russian Federation	Site reference ID/Investigator # 82495	Novosibirsk
Russian Federation	Site reference ID/Investigator # 82525	Novosibirsk
Russian Federation	Site reference ID/Investigator # 82517	St. Petersburg
Russian Federation	Site reference ID/Investigator # 82518	St. Petersburg
Russian Federation	Site reference ID/Investigator # 82519	St. Petersburg
Russian Federation	Site reference ID/Investigator # 82522	St. Petersburg
Russian Federation	Site reference ID/Investigator # 82524	St. Petersburg
Russian Federation	Site reference ID/Investigator # 82527	St. Petersburg
Russian Federation	Site reference ID/Investiragor # 82523	St. Petersburg
United Kingdom	Site Reference ID/Investigator# 74057	Birmingham
United Kingdom	Site Reference ID/Investigator# 74059	Cardiff
United Kingdom	Site Reference ID/Investigator# 74056	Chorley
United Kingdom	Site reference ID/Investigator # 95456	Glasgow
United Kingdom	Site Reference ID/Investigator# 74054	Glasgow
United Kingdom	Site Reference ID/Investigator# 74053	Liverpool
United Kingdom	Site reference ID/Investigator # 95457	London
United Kingdom	Site Reference ID/Investigator# 74055	Manchester
United Kingdom	Site reference ID/Investigator # 95455	Northwood
United Kingdom	Site Reference ID/Investigator# 74058	Reading

Sponsors (4)

Lead Sponsor	Collaborator
Abbott	author! et al. BV, Quintiles, Inc., Synexus

Countries where clinical trial is conducted

Germany,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline of diastolic blood pressure (DBP), sitting	8 weeks	No