Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Isosorbide mononitrate · 1 trial · 1 indication
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...
Isosorbide mononitrate is a small molecule being studied for the treatment of hypertension, a cardiovascular condition. It is currently in Phase 1 clinical development and is not yet approved for any use. The drug is being investigated for its effects on blood pressure in patients with hypertension.
Isosorbide mononitrate is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with hypertension.
Isosorbide mononitrate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being evaluated for its effects on glucose homeostasis in patients with hypertension.
Isosorbide mononitrate has one completed Phase 1 clinical trial registered as NCT00871871. The trial, titled "Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)", enrolled 64 participants with hypertension. The study was randomized, double-blind, and controlled.
Isosorbide mononitrate is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hypertension. The completed Phase 1 trial evaluated the drug's effects on glucose homeostasis, but the drug has not yet received regulatory approval for any indication.