Trial Outcomes & Findings for A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED) (NCT NCT00886600)
NCT ID: NCT00886600
Last Updated: 2015-08-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
122 participants
Primary outcome timeframe
24 hour period at Baseline and Week 4
Results posted on
2015-08-27
Participant Flow
Patients were recruited at 9 sites in the United States. Prime Therapy Period: May, 1991 to March, 1992.
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Double-blind Monotherapy
STARTED
|
32
|
29
|
30
|
31
|
|
Double-blind Monotherapy
COMPLETED
|
30
|
28
|
29
|
29
|
|
Double-blind Monotherapy
NOT COMPLETED
|
2
|
1
|
1
|
2
|
|
Combination Therapy Period
STARTED
|
28
|
21
|
21
|
23
|
|
Combination Therapy Period
COMPLETED
|
28
|
21
|
19
|
23
|
|
Combination Therapy Period
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Double-blind Monotherapy
Adverse Event
|
1
|
1
|
1
|
1
|
|
Double-blind Monotherapy
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Double-blind Monotherapy
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Combination Therapy Period
Adverse Event
|
0
|
0
|
1
|
0
|
|
Combination Therapy Period
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Placebo / HCTZ 12.5 mg
n=32 Participants
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
n=29 Participants
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
n=30 Participants
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
n=31 Participants
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
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
56.8 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
51.2 years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
54.1 years
STANDARD_DEVIATION 9.0 • n=483 Participants
|
53.5 years
STANDARD_DEVIATION 10.8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
39 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
83 Participants
n=36 Participants
|
|
Race/Ethnicity
Caucasian
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
30 participants
n=27 Participants
|
30 participants
n=483 Participants
|
119 participants
n=36 Participants
|
|
Race/Ethnicity
Oriental
|
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
|
|
Race/Ethnicity
Filipino
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Race/Ethnicity
Indian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
|
Diastolic 24-hr mean ambulatory blood pressure monitoring (ABPM)
|
94.8 mm Hg
STANDARD_DEVIATION 5.9 • n=93 Participants
|
94.0 mm Hg
STANDARD_DEVIATION 6.9 • n=4 Participants
|
93.8 mm Hg
STANDARD_DEVIATION 6.0 • n=27 Participants
|
94.4 mm Hg
STANDARD_DEVIATION 6.9 • n=483 Participants
|
94.2 mm Hg
STANDARD_DEVIATION 6.4 • n=36 Participants
|
|
Sitting Diastolic Blood Pressure (SiDBP)
|
100.7 mm Hg
STANDARD_DEVIATION 4.0 • n=93 Participants
|
100.0 mm Hg
STANDARD_DEVIATION 4.6 • n=4 Participants
|
101.5 mm Hg
STANDARD_DEVIATION 5.1 • n=27 Participants
|
101.2 mm Hg
STANDARD_DEVIATION 4.8 • n=483 Participants
|
100.9 mm Hg
STANDARD_DEVIATION 4.6 • n=36 Participants
|
PRIMARY outcome
Timeframe: 24 hour period at Baseline and Week 4Population: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.
Outcome measures
| Measure |
Placebo / HCTZ 12.5 mg
n=26 Participants
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
n=28 Participants
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
n=28 Participants
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
n=30 Participants
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
|
|---|---|---|---|---|
|
Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
|
-0.2 mm Hg
Standard Deviation 4.8
|
-5.2 mm Hg
Standard Deviation 5.1
|
-6.4 mm Hg
Standard Deviation 5.5
|
-8.5 mm Hg
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: 24-hour period at baseline and Week 4Population: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.
Outcome measures
| Measure |
Placebo / HCTZ 12.5 mg
n=26 Participants
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
n=28 Participants
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
n=28 Participants
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
n=30 Participants
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
|
|---|---|---|---|---|
|
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
|
0 mm Hg
Standard Deviation 7.8
|
-9.2 mm Hg
Standard Deviation 9.9
|
-9.9 mm Hg
Standard Deviation 7.6
|
-13.2 mm Hg
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline and 24-hours after morning dose at Week 4Population: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.
Outcome measures
| Measure |
Placebo / HCTZ 12.5 mg
n=30 Participants
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
n=29 Participants
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
n=28 Participants
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
n=30 Participants
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
|
|---|---|---|---|---|
|
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
|
-2.1 mm Hg
Standard Deviation 6.9
|
-6.7 mm Hg
Standard Deviation 7.8
|
-9.6 mm Hg
Standard Deviation 6.5
|
-8.8 mm Hg
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and 24-hours after morning dose at Week 6Population: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.
Outcome measures
| Measure |
Placebo / HCTZ 12.5 mg
n=26 Participants
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
n=21 Participants
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
n=16 Participants
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
n=20 Participants
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
|
|---|---|---|---|---|
|
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
|
-4.6 mm Hg
Standard Deviation 6.1
|
-9.9 mm Hg
Standard Deviation 6.3
|
-10.7 mm Hg
Standard Deviation 4.9
|
-10.1 mm Hg
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and 24-hours after morning dose at Week 6Population: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.
Outcome measures
| Measure |
Placebo / HCTZ 12.5 mg
n=26 Participants
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
n=21 Participants
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
n=16 Participants
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
n=20 Participants
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
|
|---|---|---|---|---|
|
Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
|
-4.0 mm Hg
Standard Deviation 6.4
|
-5.1 mm Hg
Standard Deviation 7.8
|
-4.0 mm Hg
Standard Deviation 6.1
|
-4.0 mm Hg
Standard Deviation 6.9
|
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 Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER