Trial Outcomes & Findings for MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension (NCT NCT00888355)
NCT ID: NCT00888355
Last Updated: 2009-07-09
Results Overview
Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12
COMPLETED
PHASE3
428 participants
At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)
2009-07-09
Participant Flow
Patients were recruited at 37 sites in the United States. Prime Therapy Period: May, 1992 to January1993
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 did not differ by \>7 mm Hg.
Participant milestones
| Measure |
Placebo
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
108
|
108
|
106
|
106
|
|
Overall Study
COMPLETED
|
86
|
99
|
94
|
96
|
|
Overall Study
NOT COMPLETED
|
22
|
9
|
12
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
0
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
9
|
2
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
3
|
Baseline Characteristics
MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=108 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=108 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=106 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=106 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Vietnamese
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Sitting Diastolic Blood Pressure (SiDBP)
|
101.5 mm Hg
STANDARD_DEVIATION 5.1 • n=93 Participants
|
101.8 mm Hg
STANDARD_DEVIATION 5.5 • n=4 Participants
|
102.4 mm Hg
STANDARD_DEVIATION 6.4 • n=27 Participants
|
102.0 mm Hg
STANDARD_DEVIATION 5.3 • n=483 Participants
|
101.9 mm Hg
STANDARD_DEVIATION 5.6 • n=36 Participants
|
|
Age Continuous
|
54.6 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
53.0 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION 10.1 • n=27 Participants
|
52.4 years
STANDARD_DEVIATION 10.1 • n=483 Participants
|
53.5 years
STANDARD_DEVIATION 10.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
151 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
277 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
84 participants
n=93 Participants
|
79 participants
n=4 Participants
|
82 participants
n=27 Participants
|
89 participants
n=483 Participants
|
334 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
7 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 participants
n=93 Participants
|
22 participants
n=4 Participants
|
17 participants
n=27 Participants
|
10 participants
n=483 Participants
|
70 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
15 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)Population: The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.
Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12
Outcome measures
| Measure |
Placebo
n=102 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=101 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=101 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
|
-2.0 mm Hg
Standard Deviation 8.4
|
-5.8 mm Hg
Standard Deviation 6.7
|
-6.3 mm Hg
Standard Deviation 7.4
|
-8.0 mm Hg
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)Population: An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.
Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12
Outcome measures
| Measure |
Placebo
n=102 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=101 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=101 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12
|
-0.2 mm Hg
Standard Deviation 15.1
|
-7.2 mm Hg
Standard Deviation 13.9
|
-7.6 mm Hg
Standard Deviation 12.6
|
-8.8 mm Hg
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: At baseline and at 12 weeks (6 hours after last morning dose)Population: An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.
Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12
Outcome measures
| Measure |
Placebo
n=92 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=95 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=94 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=94 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
|
-3.0 mm Hg
Standard Deviation 9.7
|
-7.7 mm Hg
Standard Deviation 8.5
|
-8.7 mm Hg
Standard Deviation 8.1
|
-9.9 mm Hg
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeksPopulation: An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.
Patients with trough SiDBP \<90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III.
Outcome measures
| Measure |
Placebo
n=102 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=101 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=101 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Category II
|
10 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
|
Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Category III
|
80 Participants
|
68 Participants
|
61 Participants
|
53 Participants
|
|
Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Category I
|
12 Participants
|
23 Participants
|
26 Participants
|
33 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication were included in the analysis.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=108 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=108 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=106 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=106 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients With Clinical Adverse Experiences (CAEs)
With CAEs
|
63 Participants
|
59 Participants
|
59 Participants
|
60 Participants
|
|
Number of Patients With Clinical Adverse Experiences (CAEs)
Without CAEs
|
45 Participants
|
49 Participants
|
47 Participants
|
46 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication were included in the analysis.
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Placebo
n=108 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=108 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=106 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=106 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients With Serious CAEs
With Serious CAEs
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Serious CAEs
Without Serious CAEs
|
104 Participants
|
107 Participants
|
105 Participants
|
103 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication were included in the analysis.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period
Outcome measures
| Measure |
Placebo
n=108 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=108 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=106 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=106 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients With Drug-related CAEs
With drug-related CAEs
|
20 Participants
|
12 Participants
|
21 Participants
|
16 Participants
|
|
Number of Patients With Drug-related CAEs
Without drug-related CAEs
|
88 Participants
|
96 Participants
|
85 Participants
|
90 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication were included in the analysis.
Patients discontinued due to CAEs during the 12-week treatment period
Outcome measures
| Measure |
Placebo
n=108 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=108 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=106 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=106 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients Discontinued Due to CAEs
Discontinued due to CAEs
|
10 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients Discontinued Due to CAEs
Not discontinued due to CAEs
|
98 Participants
|
108 Participants
|
105 Participants
|
103 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication were included in the analysis.
Patients who died during the 12-week treatment period
Outcome measures
| Measure |
Placebo
n=108 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=108 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=106 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=106 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients Who Died
Who Died
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Died
Alive
|
106 Participants
|
108 Participants
|
106 Participants
|
105 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication and had any laboratory tests performed were included in the analysis.
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=104 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=103 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=104 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients With Laboratory Adverse Experiences (LAEs)
With LAEs
|
7 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Number of Patients With Laboratory Adverse Experiences (LAEs)
Without LAEs
|
97 Participants
|
98 Participants
|
96 Participants
|
100 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication and had any laboratory tests performed were included in the analysis.
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Placebo
n=104 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=103 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=104 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients With Serious LAEs
With serious LAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Serious LAEs
Without serious LAEs
|
104 Participants
|
105 Participants
|
103 Participants
|
104 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication and had any laboratory tests performed were included in the analysis.
Patients with drug-related LAEs during the 12-week treatment period
Outcome measures
| Measure |
Placebo
n=104 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=103 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=104 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients With Drug-related LAEs
With drug-related LAEs
|
4 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Drug-related LAEs
Without drug-related LAEs
|
100 Participants
|
100 Participants
|
99 Participants
|
104 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All patients who took study medication and had any laboratory tests performed were included in the analysis
Patients discontinued due to LAEs during the 12-week treatment period
Outcome measures
| Measure |
Placebo
n=104 Participants
Losartan placebo orally once daily for 12 weeks
|
Losartan 25 mg q.d.
n=105 Participants
Losartan 25 mg orally once daily (q.d.) for 12 weeks
|
Losartan 50 mg q.d.
n=103 Participants
Losartan 50 mg orally once daily (q.d.) for 12 weeks
|
Losartan 25 mg (b.i.d.)
n=104 Participants
Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
|
|---|---|---|---|---|
|
Number of Patients Discontinued Due to LAEs
Not discontinued due to LAEs
|
104 Participants
|
105 Participants
|
101 Participants
|
104 Participants
|
|
Number of Patients Discontinued Due to LAEs
Discontinued due to LAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck & Co., Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place