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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01631227
First Posted: June 29, 2012
Last Update Posted: July 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Quintiles, Inc.
Synexus
author! et al. BV
Information provided by (Responsible Party):
Abbott
June 27, 2012
June 29, 2012
April 28, 2014
May 26, 2014
July 25, 2014
June 2012
April 2013   (Final data collection date for primary outcome measure)
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 [ Time Frame: 8 weeks ]
Change from baseline of diastolic blood pressure (DBP), sitting
Assess the therapeutic equivalence of eprosartan (a new formulation containing only the active moiety eprosartan) with eprosartan mesylate (currently marketed formulation) on sitting diastolic blood pressure (DBP) [ Time Frame: 8 weeks ]
Sitting diastolic blood pressure (DBP)
Complete list of historical versions of study NCT01631227 on ClinicalTrials.gov Archive Site
Not Provided
  • Compare the effect of eprosartan with eprosartan mesylate on sitting systolic blood pressure (SBP) [ Time Frame: 8 weeks ]
    Change in trough sitting SBP from baseline to end of Week 8
  • Compare the effect of eprosartan with eprosartan mesylate on sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: 12 weeks ]
    Change in trough sitting DBP and though sitting SBP from baseline to end of Week 12
  • Compare the effect of eprosartan with eprosartan mesylate on normalization rate on monotherapy at week 8 and week 12 [ Time Frame: 4 weeks ]
    Normalization rate at week 8 and week 12
  • Compare the effect of eprosartan with eprosartan mesylate on responder rate on monotherapy at week 8 and week 12 [ Time Frame: 4 weeks ]
    Responder rate at week 8 and week 12
  • Compare the effect of eprosartan with eprosartan mesylate on normalization rate with hydrochlorothiazide add-on therapy at week 12 [ Time Frame: 12 weeks ]
    normalization rate at week 12
  • Compare the effect of eprosartan with eprosartan mesylate on responder rate with hydrochlorothiazide add-on therapy at week 12 [ Time Frame: 12 weeks ]
    responder rate at week 12
  • Number of subjects with adverse events [ Time Frame: 12 weeks ]
  • Vital signs [ Time Frame: 12 weeks ]
  • Physical examination findings [ Time Frame: 12 weeks ]
  • Safety Laboratory Values [ Time Frame: 12 weeks ]

    Hematology: hemoglobin, hematocrit, red blood count (RBC), white blood count (WBC), differential count, platelets and HbA1c (only at V1).

    Biochemistry: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, urea, blood urea nitrogen (BUN), sodium, potassium, glucose

Not Provided
Not Provided
 
Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: Eprosartan
    Eprosartan 450 mg
  • Drug: Eprosartan Mesylate
    Eprosartan mesylate 600 mg
    Other Names:
    • ABT-139
    • Teveten
  • Drug: Placebo Eprosartan mesylate
    Placebo Eprosartan mesylate
    Other Name: Placebo
  • Drug: Placebo Eprosartan
    Placebo Eprosartan
    Other Name: Placebo
  • Experimental: Eprosartan
    Eprosartan + Placebo Eprosartan Mesylate
    Interventions:
    • Drug: Eprosartan
    • Drug: Placebo Eprosartan mesylate
  • Active Comparator: Eprosartan Mesylate
    Eprosartan Mesylate + Placebo Eprosartan
    Interventions:
    • Drug: Eprosartan Mesylate
    • Drug: Placebo Eprosartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
665
April 2013
April 2013   (Final data collection date for primary outcome measure)

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%)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Russian Federation,   United Kingdom
 
 
NCT01631227
M13-385
2010-019432-12 ( EudraCT Number )
No
Not Provided
Not Provided
Abbott
Abbott
  • Quintiles, Inc.
  • Synexus
  • author! et al. BV
Study Director: Dmitri N. Kazei, MD Abbott Healthcare Products B.V.
Abbott
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP