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A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00886600
First received: April 22, 2009
Last updated: July 27, 2009
Last verified: July 2009
History of Changes
Results First Received: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium
Drug: Comparator: placebo
Drug: hydrochlorothiazide (HCTZ)

  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
Patients were recruited at 9 sites in the United States. Prime Therapy Period: May, 1991 to March, 1992.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients could be randomized if sitting diastolic blood pressure (SiDBP) after 2 and 4 weeks of placebo washout was 95-115 mm Hg and the difference between measurements at the 2 visits was ≤7 mm Hg. At the end of placebo baseline the mean 24-hr DBP using ambulatory blood pressure monitoring (ABPM) had to be at least 85 mm Hg.

Reporting Groups
  Description
Placebo / HCTZ 12.5 mg

Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks

Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks
Losartan 50 mg q.d. / HCTZ 12.5 mg

Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks

Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks
Losartan 100 mg q.d. / HCTZ 12.5 mg

Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks

Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks
Losartan 50 mg b.i.d. / HCTZ 12.5 mg

Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks

Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks

Participant Flow for 2 periods

 Period 1:   Double-blind Monotherapy
    Placebo / HCTZ 12.5 mg     Losartan 50 mg q.d. / HCTZ 12.5 mg     Losartan 100 mg q.d. / HCTZ 12.5 mg     Losartan 50 mg b.i.d. / HCTZ 12.5 mg  
STARTED     32     29     30     31  
COMPLETED     30     28 [1]   29     29  
NOT COMPLETED     2     1     1     2  
Adverse Event                 1                 1                 1                 1  
Protocol Violation                 0                 0                 0                 1  
Withdrawal by Subject                 1                 0                 0                 0  
[1] 1 pt discontinued after Wk 4 due to AE starting in placebo baseline and continuing into double-blind

Period 2:   Combination Therapy Period
    Placebo / HCTZ 12.5 mg     Losartan 50 mg q.d. / HCTZ 12.5 mg     Losartan 100 mg q.d. / HCTZ 12.5 mg     Losartan 50 mg b.i.d. / HCTZ 12.5 mg  
STARTED     28 [1]   21 [2]   21 [3]   23 [4]
COMPLETED     28     21     19     23  
NOT COMPLETED     0     0     2     0  
Adverse Event                 0                 0                 1                 0  
Protocol Violation                 0                 0                 1                 0  
[1] Patients did not continue from monotherapy period : 2-(Sitting Diastolic Blood Pressure (SiDBP) <85)
[2] Patients did not continue from monotherapy period : 4-(SiDBP <85); 3-(SiDBP ≥85)
[3] Patients did not continue from monotherapy period : 7-(SiDBP <85); 1-(SiDBP ≥85)
[4] Patients did not continue from monotherapy period : 5-(SiDBP <85); 1-(SiDBP ≥85)



  Baseline Characteristics
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Reporting Groups
  Description
Placebo / HCTZ 12.5 mg Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
Losartan 50 mg q.d. / HCTZ 12.5 mg Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
Losartan 100 mg q.d. / HCTZ 12.5 mg Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
Losartan 50 mg b.i.d. / HCTZ 12.5 mg Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo / HCTZ 12.5 mg     Losartan 50 mg q.d. / HCTZ 12.5 mg     Losartan 100 mg q.d. / HCTZ 12.5 mg     Losartan 50 mg b.i.d. / HCTZ 12.5 mg     Total  
Number of Participants  
[units: participants]
 		  32     29     30     31     122  
Age  
[units: years]
Mean ± Standard Deviation 		  52.2  ± 12.0     56.8  ± 12.1     51.2  ± 9.6     54.1  ± 9.0     53.5  ± 10.8  
Gender  
[units: participants]
 		         
Female     7     10     9     13     39  
Male     25     19     21     18     83  
Race/Ethnicity  
[units: participants]
 		         
Caucasian     30     29     30     30     119  
Oriental     0     0     0     1     1  
Filipino     1     0     0     0     1  
Indian     1     0     0     0     1  
Diastolic 24-hr mean ambulatory blood pressure monitoring (ABPM)  
[units: mm Hg]
Mean ± Standard Deviation 		  94.8  ± 5.9     94.0  ± 6.9     93.8  ± 6.0     94.4  ± 6.9     94.2  ± 6.4  
Sitting Diastolic Blood Pressure (SiDBP)  
[units: mm Hg]
Mean ± Standard Deviation 		  100.7  ± 4.0     100.0  ± 4.6     101.5  ± 5.1     101.2  ± 4.8     100.9  ± 4.6  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4   [ Time Frame: 24 hour period at Baseline and Week 4 ]
  Show Outcome Measure 1

2.  Primary:   Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4   [ Time Frame: 24-hour period at baseline and Week 4 ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4   [ Time Frame: Baseline and 24-hours after morning dose at Week 4 ]
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4.  Secondary:   Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6   [ Time Frame: Baseline and 24-hours after morning dose at Week 6 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6   [ Time Frame: Baseline and 24-hours after morning dose at Week 6 ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Safety has been reported in the literature.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372


Publications:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00886600     History of Changes
Other Study ID Numbers: 2009_581, MK0954-021
Study First Received: April 22, 2009
Results First Received: May 21, 2009
Last Updated: July 27, 2009
Health Authority: United States: Food and Drug Administration