| Trial ID: | L5790 |
| Source ID: | NCT00806585
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| Associated Drug: |
Mk-0736
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| Title: |
Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00806585/results
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| Conditions: |
Type 2 Diabetes Mellitus|Hypertension
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| Interventions: |
DRUG: MK-0736|DRUG: Comparator: Placebo|DRUG: Comparator: HCTZ
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| Outcome Measures: |
Primary: Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12, Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded., Baseline and Week 12|Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12, Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded., Baseline and Week 12 | Secondary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12, LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration, Baseline and Week 12|Change From Baseline in Body Weight at Week 24, Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study., Baseline and Week 24|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24, HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration, Baseline and Week 24
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| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
620
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2008-12
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| Completion Date: |
2010-06
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| Results First Posted: |
2013-12-11
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| Last Update Posted: |
2015-09-21
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT00806585
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