Trial Outcomes & Findings for A Study to Investigate the Antihypertensive Efficacy of MK0954 (NCT NCT00887250)

NCT ID: NCT00887250

Last Updated: 2009-07-14

Results Overview

Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 366 participants
• Primary outcome timeframe: At baseline and at 12 weeks (24 hours post dose)
• Results posted on: 2009-07-14

Participant Flow

Patients were recruited at 22 sites in the United States. Prime Therapy Period: December, 1991 to August, 1992.

Patients could be randomized after the 4-week placebo baseline period if their mean sitting diastolic blood pressure (SiDBP) was 95-115 mm Hg and ≤7 mm Hg from the mean SiDBP after 2 weeks of placebo therapy

Participant milestones

Measure	Placebo Losartan placebo orally once daily for 12 weeks	Losartan 50 mg Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Overall Study STARTED	116	127	123
Overall Study COMPLETED	98	115	110
Overall Study NOT COMPLETED	18	12	13

Reasons for withdrawal

Measure	Placebo Losartan placebo orally once daily for 12 weeks	Losartan 50 mg Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Overall Study Adverse Event	3	0	7
Overall Study Lack of Efficacy	9	6	1
Overall Study Lost to Follow-up	2	3	1
Overall Study Protocol Violation	2	2	1
Overall Study Withdrawal by Subject	2	1	2
Overall Study Patient uncooperative	0	0	1

Baseline Characteristics

A Study to Investigate the Antihypertensive Efficacy of MK0954

Baseline characteristics by cohort

Measure	Placebo n=116 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=127 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=123 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks	Total n=366 Participants Total of all reporting groups
Age Continuous	53.8 years n=93 Participants	53.2 years n=4 Participants	55.1 years n=27 Participants	54.0 years n=483 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	44 Participants n=4 Participants	45 Participants n=27 Participants	131 Participants n=483 Participants
Sex: Female, Male Male	74 Participants n=93 Participants	83 Participants n=4 Participants	78 Participants n=27 Participants	235 Participants n=483 Participants
Race/Ethnicity, Customized Caucasian	92 participants n=93 Participants	104 participants n=4 Participants	101 participants n=27 Participants	297 participants n=483 Participants
Race/Ethnicity, Customized Black	17 participants n=93 Participants	14 participants n=4 Participants	16 participants n=27 Participants	47 participants n=483 Participants
Race/Ethnicity, Customized Hispanic	7 participants n=93 Participants	8 participants n=4 Participants	4 participants n=27 Participants	19 participants n=483 Participants
Race/Ethnicity, Customized Indian	0 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants
Race/Ethnicity, Customized Oriental	0 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants	2 participants n=483 Participants
Sitting Diastolic Blood Pressure (SiDBP)	101.3 mm Hg n=93 Participants	102.2 mm Hg n=4 Participants	102.2 mm Hg n=27 Participants	101.9 mm Hg n=483 Participants

PRIMARY outcome

Timeframe: At baseline and at 12 weeks (24 hours post 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 post dose) SiDBP at Week 12

Outcome measures

Measure	Placebo n=114 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=125 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=118 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12	-4.3 mm Hg Standard Deviation 6.7	-7.9 mm Hg Standard Deviation 7.6	-8.6 mm Hg Standard Deviation 7.7

SECONDARY outcome

Timeframe: 24 hours post dose at Week 6

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.

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 were in Category III.

Outcome measures

Measure	Placebo n=114 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=125 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=118 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 Category II	8 Participants	20 Participants	21 Participants
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 Category III	92 Participants	68 Participants	60 Participants
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 Category I	14 Participants	37 Participants	37 Participants

SECONDARY outcome

Timeframe: 24 hours post dose at Week 12

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.

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 were in Category III.

Outcome measures

Measure	Placebo n=114 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=125 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=118 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 Category II	12 Participants	18 Participants	24 Participants
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 Category I	19 Participants	40 Participants	37 Participants
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 Category III	83 Participants	67 Participants	57 Participants

SECONDARY outcome

Timeframe: At baseline and at 6 weeks (24 hours post 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 post dose) SiDBP at Week 6

Outcome measures

Measure	Placebo n=114 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=125 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=118 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6	-3.5 mm Hg Standard Deviation 5.8	-6.9 mm Hg Standard Deviation 7.0	-7.9 mm Hg Standard Deviation 7.1

SECONDARY outcome

Timeframe: At baseline and at 6 weeks (24 hours post 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 peak (6 hours post dose) SiDBP at Week 6

Outcome measures

Measure	Placebo n=108 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=118 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=111 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6	-4.1 mm Hg Standard Deviation 6.9	-9.7 mm Hg Standard Deviation 8.7	-8.9 mm Hg Standard Deviation 8.7

SECONDARY outcome

Timeframe: At baseline and at 12 weeks (6 hours post 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 peak (6 hours post dose) SiDBP at Week 12

Outcome measures

Measure	Placebo n=108 Participants Losartan placebo orally once daily for 12 weeks	Losartan 50 mg n=121 Participants Losartan 50 mg orally once daily for 12 weeks	Losartan 50/100 mg n=113 Participants Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12	-4.7 mm Hg Standard Deviation 7.9	-9.5 mm Hg Standard Deviation 9.2	-10.1 mm Hg Standard Deviation 8.6

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.

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place