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BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333) (EASE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00546754
First received: October 17, 2007
Last updated: October 9, 2015
Last verified: October 2015
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium (+) hydrochlorothiazide
Drug: Comparator: Valsartan (+) Hydrochlorothiazide

  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

First patient in: MAY-04-2007

Last patient out: APRIL-16-2009

Total number of sites: 163 sites in Canada


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
Losartan 50 mg/HCTZ 12.5 mg Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Valsartan 80 mg/HCTZ 12.5 mg Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Participant Flow:   Overall Study
    Losartan 50 mg/HCTZ 12.5 mg   Valsartan 80 mg/HCTZ 12.5 mg
STARTED   425 [1]   383 [1] 
Treated   416 [2]   373 [2] 
Week 6   396   347 
Week 12   375   334 
COMPLETED   375   334 
NOT COMPLETED   50   49 
Serious Adverse Event                1                1 
Adverse Event                11                16 
Lack of Efficacy                1                1 
Lost to Follow-up                9                15 
Protocol Violation                3                0 
Withdrawal by Subject                6                7 
Dyspnea                1                0 
Per Data Query, Less Than 4 Wks Coversyl                1                0 
Hip Replacement                1                0 
Suicide                1                0 
Missing Cooperation                1                0 
Elevated Creatinine and Potassium levels                0                1 
Patient's Decision                0                1 
Missing                14                7 
[1] Number of patients enrolled and randomized
[2] Patients that received at least one dose of study medication and had 1 follow-up visit



  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.
No text entered.

Reporting Groups
  Description
Losartan 50 mg/HCTZ 12.5 mg

Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])

Valsartan 80 mg/HCTZ 12.5 mg

Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])

Total Total of all reporting groups

Baseline Measures
   Losartan 50 mg/HCTZ 12.5 mg   Valsartan 80 mg/HCTZ 12.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 416   373   789 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (11.11)   58.3  (10.26)   58.5  (10.71) 
Gender 
[Units: Participants]
     
Female   197   180   377 
Male   219   193   412 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   364   326   690 
Black   8   13   21 
Hispanic   2   0   2 
Asian   34   29   63 
Native   4   4   8 
East Indian   1   0   1 
From Middle East   1   0   1 
Unknown   2   1   3 


  Outcome Measures
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1.  Primary:   Change in Systolic Blood Pressure From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Change in Diastolic Blood Pressure From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change in Systolic Blood Pressure From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

4.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

5.  Secondary:   Number of Patients Achieving Target Blood Pressure at Week 6   [ Time Frame: Week 6 ]

6.  Secondary:   Number of Patients Achieving Target Blood Pressure at Week 12   [ Time Frame: 12 Weeks ]

7.  Secondary:   Time to Achieve Target Blood Pressure   [ Time Frame: 12 weeks ]

8.  Secondary:   Change in Uric Acid From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:   Change in Uric Acid From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

11.  Secondary:   Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

13.  Secondary:   Change in Gamma-Glutamyl Transpeptidase (Gamma–GT) From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00546754     History of Changes
Other Study ID Numbers: 0954A-333
MK0954A-333
2007_031
Study First Received: October 17, 2007
Results First Received: March 26, 2010
Last Updated: October 9, 2015
Health Authority: Canada: Health Canada