Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00871871 | Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed) | PHASE1 | COMPLETED | 64 | — | — | Mar 1, 2009 | Mar 1, 2010 | Jul 28, 2015 | - | — |
Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose \>= 140 and \<= 199 mg/dL during a 75g oral glucose tolerance test at screening.
Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.
Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG \<100 mg/dL \& 2 hour plasma glucose (PG) \<140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose \>= 140 and \<= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening.
Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.
| Arm | Type | Description |
|---|---|---|
| Part I, Placebo-HCTZ | EXPERIMENTAL | Placebo in Period 1 followed by HCTZ in Period 2 |
| Part I, HCTZ-Placebo | EXPERIMENTAL | HCTZ in Period 1, followed by placebo in Period 2 |
| Part II, Placebo-ISMN | EXPERIMENTAL | Placebo in Period 1, followed by ISMN in Period 2 |
| Part II, ISMN-Placebo | EXPERIMENTAL | ISMN in Period 1, followed by placebo in Period 2 |
| Name | Type | Description |
|---|---|---|
| Hydrochlorothiazide (HCTZ) | DRUG | HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period. |
| Comparator: Placebo to HCTZ | DRUG | Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period |
| Isosorbide mononitrate (ISMN) | DRUG | ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period |
| Comparator: Placebo to ISMN | DRUG | Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period |
Inclusion Criteria: * Female participants must be post-menopausal * Body Mass Index (BMI) of at least 29 kg/m\^2 * Weight has been stable over the past 3 months * Has never been treated for hypertension or is diagnosed with hypertension taking up to 2 anti-hypertensive medications * Willing to stop...