Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011) (NCT NCT00882440)

NCT ID: NCT00882440

Last Updated: 2015-08-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 576 participants
• Primary outcome timeframe: 24 hours post dose at Baseline and Week 8
• Results posted on: 2015-08-27

Participant Flow

Patients were recruited at 28 sites in the United States. Primary Therapy Period: December, 1990-August, 1991

Patients could be randomized after the 4-week placebo baseline period if their mean supine diastolic blood pressure (SuDBP) was 100-115 mmHg and ≤7 mmHg from the mean SuDBP after 2 weeks of placebo therapy, or after a 2-week placebo baseline period if 2 sets of SuDBP data were within 100-115 mmHg, ≥3 days apart and differed by ≤7 mmHg.

Participant milestones

Measure	Placebo Losartan and Enalapril placebo orally once daily for 8 weeks	Losartan 10 mg Losartan 10 mg orally once daily for 8 weeks	Losartan 25 mg Losartan 25 mg orally once daily for 8 weeks	Losartan 50 mg Losartan 50 mg orally once daily for 8 weeks	Losartan 100 mg Losartan 100 mg orally once daily for 8 weeks	Losartan 150 mg Losartan 150 mg orally once daily for 8 weeks	Enalapril 20 Enalapril 20 mg orally once daily for 8 weeks
Overall Study STARTED	78	80	82	79	90	84	83
Overall Study COMPLETED	67	72	75	76	80	77	79
Overall Study NOT COMPLETED	11	8	7	3	10	7	4

Reasons for withdrawal

Measure	Placebo Losartan and Enalapril placebo orally once daily for 8 weeks	Losartan 10 mg Losartan 10 mg orally once daily for 8 weeks	Losartan 25 mg Losartan 25 mg orally once daily for 8 weeks	Losartan 50 mg Losartan 50 mg orally once daily for 8 weeks	Losartan 100 mg Losartan 100 mg orally once daily for 8 weeks	Losartan 150 mg Losartan 150 mg orally once daily for 8 weeks	Enalapril 20 Enalapril 20 mg orally once daily for 8 weeks
Overall Study Adverse Event	2	2	2	1	1	4	2
Overall Study Lack of Efficacy	3	5	2	0	0	3	0
Overall Study Lost to Follow-up	2	0	1	1	1	0	1
Overall Study Protocol Violation	0	0	1	1	1	0	0
Overall Study Withdrawal by Subject	2	1	1	0	6	0	1
Overall Study Patient Uncooperative	2	0	0	0	1	0	0

Baseline Characteristics

A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

Baseline characteristics by cohort

Measure	Placebo n=78 Participants Losartan and Enalapril placebo orally once daily for 8 weeks	Losartan 10 mg n=80 Participants Losartan 10 mg orally once daily for 8 weeks	Losartan 25 mg n=82 Participants Losartan 25 mg orally once daily for 8 weeks	Losartan 50 mg n=79 Participants Losartan 50 mg orally once daily for 8 weeks	Losartan 100 mg n=90 Participants Losartan 100 mg orally once daily for 8 weeks	Losartan 150 mg n=84 Participants Losartan 150 mg orally once daily for 8 weeks	Enalapril 20 n=83 Participants Enalapril 20 mg orally once daily for 8 weeks	Total n=576 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 11.6 • n=5 Participants	53.9 years STANDARD_DEVIATION 12.3 • n=7 Participants	52.8 years STANDARD_DEVIATION 12.2 • n=5 Participants	52.8 years STANDARD_DEVIATION 10.3 • n=4 Participants	54.0 years STANDARD_DEVIATION 10.2 • n=21 Participants	53.9 years STANDARD_DEVIATION 10.8 • n=8 Participants	51.9 years STANDARD_DEVIATION 11.1 • n=8 Participants	53.1 years STANDARD_DEVIATION 11.2 • n=24 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	31 Participants n=21 Participants	22 Participants n=8 Participants	27 Participants n=8 Participants	193 Participants n=24 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	51 Participants n=7 Participants	55 Participants n=5 Participants	53 Participants n=4 Participants	59 Participants n=21 Participants	62 Participants n=8 Participants	56 Participants n=8 Participants	383 Participants n=24 Participants
Race/Ethnicity Caucasian	64 participants n=5 Participants	60 participants n=7 Participants	63 participants n=5 Participants	57 participants n=4 Participants	66 participants n=21 Participants	64 participants n=8 Participants	64 participants n=8 Participants	438 participants n=24 Participants
Race/Ethnicity Black	5 participants n=5 Participants	10 participants n=7 Participants	14 participants n=5 Participants	11 participants n=4 Participants	17 participants n=21 Participants	11 participants n=8 Participants	7 participants n=8 Participants	75 participants n=24 Participants
Race/Ethnicity Hispanic	9 participants n=5 Participants	9 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants	7 participants n=21 Participants	8 participants n=8 Participants	10 participants n=8 Participants	59 participants n=24 Participants
Race/Ethnicity Other	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants	2 participants n=8 Participants	4 participants n=24 Participants
SuDBP	103.3 mmHg STANDARD_DEVIATION 3.8 • n=5 Participants	104.3 mmHg STANDARD_DEVIATION 3.9 • n=7 Participants	103.3 mmHg STANDARD_DEVIATION 3.7 • n=5 Participants	104.0 mmHg STANDARD_DEVIATION 3.7 • n=4 Participants	104.1 mmHg STANDARD_DEVIATION 4.2 • n=21 Participants	103.4 mmHg STANDARD_DEVIATION 3.4 • n=8 Participants	103.1 mmHg STANDARD_DEVIATION 3.7 • n=8 Participants	103.7 mmHg STANDARD_DEVIATION 3.8 • n=24 Participants

PRIMARY outcome

Timeframe: 24 hours post dose at Baseline and Week 8

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.

Outcome measures

Measure	Placebo n=78 Participants Losartan and Enalapril placebo orally once daily for 8 weeks	Losartan 10 mg n=80 Participants Losartan 10 mg orally once daily for 8 weeks	Losartan 25 mg n=82 Participants Losartan 25 mg orally once daily for 8 weeks	Losartan 50 mg n=78 Participants Losartan 50 mg orally once daily for 8 weeks	Losartan 100 mg n=89 Participants Losartan 100 mg orally once daily for 8 weeks	Losartan 150 mg n=84 Participants Losartan 150 mg orally once daily for 8 weeks	Enalapril 20 n=82 Participants Enalapril 20 mg orally once daily for 8 weeks
Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8	-5.6 mm Hg Standard Deviation 7.8	-7.9 mm Hg Standard Deviation 7.6	-6.8 mm Hg Standard Deviation 7.9	-10.1 mm Hg Standard Deviation 7.0	-9.9 mm Hg Standard Deviation 6.9	-9.7 mm Hg Standard Deviation 8.0	-11.2 mm Hg Standard Deviation 6.7

SECONDARY outcome

Timeframe: 24 hours post dose at Week 8

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 in Category I (defined as "excellent" in protocol) if SuDBP was <90 mmHg, Category II (defined as "good" in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as "fair" or "inadequate" in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg.

Outcome measures

Measure	Placebo n=78 Participants Losartan and Enalapril placebo orally once daily for 8 weeks	Losartan 10 mg n=80 Participants Losartan 10 mg orally once daily for 8 weeks	Losartan 25 mg n=82 Participants Losartan 25 mg orally once daily for 8 weeks	Losartan 50 mg n=78 Participants Losartan 50 mg orally once daily for 8 weeks	Losartan 100 mg n=89 Participants Losartan 100 mg orally once daily for 8 weeks	Losartan 150 mg n=84 Participants Losartan 150 mg orally once daily for 8 weeks	Enalapril 20 n=82 Participants Enalapril 20 mg orally once daily for 8 weeks
Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 Category I	10 Participants	19 Participants	21 Participants	24 Participants	29 Participants	28 Participants	35 Participants
Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 Category II	14 Participants	17 Participants	7 Participants	15 Participants	19 Participants	12 Participants	16 Participants
Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 Category III	54 Participants	44 Participants	54 Participants	39 Participants	41 Participants	44 Participants	31 Participants

SECONDARY outcome

Timeframe: 6 hours post dose at Baseline and 8 weeks

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.

Outcome measures

Measure	Placebo n=75 Participants Losartan and Enalapril placebo orally once daily for 8 weeks	Losartan 10 mg n=79 Participants Losartan 10 mg orally once daily for 8 weeks	Losartan 25 mg n=80 Participants Losartan 25 mg orally once daily for 8 weeks	Losartan 50 mg n=77 Participants Losartan 50 mg orally once daily for 8 weeks	Losartan 100 mg n=87 Participants Losartan 100 mg orally once daily for 8 weeks	Losartan 150 mg n=81 Participants Losartan 150 mg orally once daily for 8 weeks	Enalapril 20 n=82 Participants Enalapril 20 mg orally once daily for 8 weeks
Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8	-4.7 mm Hg Standard Deviation 8.7	-7.3 mm Hg Standard Deviation 9.4	-9.9 mm Hg Standard Deviation 8.5	-11.9 mm Hg Standard Deviation 9.2	-10.4 mm Hg Standard Deviation 8.9	-13.1 mm Hg Standard Deviation 9.0	-16.2 mm Hg Standard Deviation 10.4

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