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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:
Collaborators:
Quintiles, Inc.
Synexus
author! et al. BV
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01631227
First received: June 27, 2012
Last updated: July 18, 2014
Last verified: July 2014
Results First Received: April 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: Eprosartan
Drug: Eprosartan Mesylate
Drug: Placebo Eprosartan mesylate
Drug: Placebo Eprosartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eprosartan Eprosartan 450 mg + Placebo Eprosartan Mesylate
Eprosartan Mesylate Eprosartan Mesylate 600 mg + Placebo Eprosartan

Participant Flow:   Overall Study
    Eprosartan   Eprosartan Mesylate
STARTED   333   332 
Safety Subject Sample   332 [1]   332 
Full Analysis Set Population   330 [2]   331 [3] 
COMPLETED   303   310 
NOT COMPLETED   30   22 
withdrawn consent                27                21 
Adverse Event                1                0 
administrative                2                1 
[1] 1 patient was randomized by mistake and never received study medication.
[2] 2 patients not eligible for the Full Analysis Set due to missing post-baseline efficacy measurement
[3] 1 patient not eligible for the Full Analysis Set due to missing post-baseline efficacy measurement



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set consists of 330 and 331 patients respectively.

Reporting Groups
  Description
Eprosartan Eprosartan 450 mg + Placebo Eprosartan Mesylate
Eprosartan Mesylate Eprosartan Mesylate 600 mg + Placebo Eprosartan
Total Total of all reporting groups

Baseline Measures
   Eprosartan   Eprosartan Mesylate   Total 
Overall Participants Analyzed 
[Units: Participants]
 333   332   665 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (10)   60  (10)   60  (10) 
Gender 
[Units: Participants]
     
Female   186   201   387 
Male   144   130   274 


  Outcome Measures

1.  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   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director Clinical Services
Organization: Abbott
e-mail: taco.baardman@abbott.com



Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01631227     History of Changes
Other Study ID Numbers: M13-385
2010-019432-12 ( EudraCT Number )
Study First Received: June 27, 2012
Results First Received: April 28, 2014
Last Updated: July 18, 2014