Trial Outcomes & Findings for Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366) (NCT NCT01368185)
NCT ID: NCT01368185
Last Updated: 2022-02-09
Results Overview
SUA at baseline and Month 3.
Recruitment status
COMPLETED
Target enrollment
1705 participants
Primary outcome timeframe
Baseline and Month 3
Results posted on
2022-02-09
Participant Flow
All the medical charts of the eligible study patients were reviewed. The study index period (when patients had to have received treatment for 3 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively between November 2008 and August 2010.
1735 patients were enrolled into this study. Among them, 1705 patients were eligible after excluding 30 patients.
Participant milestones
| Measure |
All Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
Overall Study
STARTED
|
1705
|
|
Overall Study
COMPLETED
|
1705
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)
Baseline characteristics by cohort
| Measure |
All Participants
n=1705 Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
795 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
910 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 3SUA at baseline and Month 3.
Outcome measures
| Measure |
All Participants
n=1705 Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
Serum Uric Acid (SUA) Level
Baseline
|
6.4 mg/dL
Standard Deviation 1.6
|
|
Serum Uric Acid (SUA) Level
Month 3
|
6.6 mg/dL
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline and Month 3Hyperuricemia was defined as SUA \>6.6mg/dL in females and \>7.7mg/dL in males.
Outcome measures
| Measure |
All Participants
n=1705 Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
The Percentage of Patients With Hyperuricemia
Baseline
|
27.0 percent of participants
|
|
The Percentage of Patients With Hyperuricemia
Month 3
|
14.6 percent of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3DBP at baseline and month 3.
Outcome measures
| Measure |
All Participants
n=1705 Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
Diastolic Blood Pressure (DBP)
Baseline
|
89 mmHg
Standard Deviation 13
|
|
Diastolic Blood Pressure (DBP)
Month 3
|
81 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline and Month 3SBP at baseline and month 3.
Outcome measures
| Measure |
All Participants
n=1705 Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
Systolic Blood Pressure (SBP)
Baseline
|
150 mmHg
Standard Deviation 19
|
|
Systolic Blood Pressure (SBP)
Month 3
|
135 mmHg
Standard Deviation 15
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=1705 participants at risk
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
|
|---|---|
|
Nervous system disorders
Dizziness
|
0.18%
3/1705 • Number of events 3
|
|
Cardiac disorders
Tachycardia/Palpitation
|
0.12%
2/1705 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea with wheezing
|
0.06%
1/1705 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Mild cough
|
0.06%
1/1705 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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