Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

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 16, 2014
Last verified: October 2014
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


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 16, 2014
Health Authority: Canada: Health Canada