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Hydrochlorothiazide

Phase 4FDA approved

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Trials Updated: Jul 28, 2015

Hydrochlorothiazide development status

FDA approval on record Mar 6, 1998
Approval holderNovartis
ApplicationNDA020818
Highest phase Phase 4 run by Sanofi (NCT00500604)
Phase scored for MRKPhase 1
Registered trials 31 across 11 sponsors since Sep 2004

Label indication Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. FDA label

Hydrochlorothiazide target and mechanism

Molecular targetSLC12A3
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL435

Also known as Hydrochlorothiazide (HCTZ)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Hydrochlorothiazide clinical trials

Hydrochlorothiazide · 1 trial · 1 indication

Phase 1 1
NCT00871871Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)Hypertension
COMPLETED64 Analytics
PHASE1COMPLETED
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)
90 -120 minutes post-dose

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.

Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)
90 -120 minutes post-dose

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.

Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)
90 -120 minutes post-dose

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.

Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state
90 -120 minutes post-dose

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.

Secondary Endpoints

Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)
90 -120 minutes post-dose
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)
90 -120 minutes post-dose
Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)
90 -120 minutes post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part I, Placebo-HCTZEXPERIMENTALPlacebo in Period 1 followed by HCTZ in Period 2
Part I, HCTZ-PlaceboEXPERIMENTALHCTZ in Period 1, followed by placebo in Period 2
Part II, Placebo-ISMNEXPERIMENTALPlacebo in Period 1, followed by ISMN in Period 2
Part II, ISMN-PlaceboEXPERIMENTALISMN in Period 1, followed by placebo in Period 2

Interventions

NameTypeDescription
Hydrochlorothiazide (HCTZ)DRUGHCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Comparator: Placebo to HCTZDRUGPlacebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Isosorbide mononitrate (ISMN)DRUGISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Comparator: Placebo to ISMNDRUGPlacebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
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Eligibility Criteria

Age Range35 Years to 75 Years
SexALL
Healthy VolunteersNo

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...

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Frequently asked questions about Hydrochlorothiazide

What is Hydrochlorothiazide?

Hydrochlorothiazide is a small molecule drug developed by Merck & Company, Inc. (MRK) for hypertension in the cardiovascular therapeutic area. It is also known as HCTZ. The drug is in Phase 1 clinical development.

What is Hydrochlorothiazide used for in hypertension?

Hydrochlorothiazide is being studied for the treatment of hypertension. It is a small molecule developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development.

What does Hydrochlorothiazide target?

Hydrochlorothiazide targets SLC12A3 and acts as an inhibitor. SLC12A3 is the molecular target of this small molecule drug, which is being developed by Merck & Company, Inc. (MRK) for hypertension.

Who makes Hydrochlorothiazide?

Hydrochlorothiazide is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is responsible for the clinical development of this small molecule drug for hypertension.

What phase is Hydrochlorothiazide in?

Hydrochlorothiazide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for the studied indication of hypertension.

What clinical trials is Hydrochlorothiazide in?

Hydrochlorothiazide has been studied in one completed Phase 1 clinical trial, NCT00871871, titled "Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)." The trial enrolled 64 participants with hypertension and was randomized, double-blind, and controlled.

Is Hydrochlorothiazide the same as HCTZ?

Yes, Hydrochlorothiazide is also known as HCTZ. Both names refer to the same small molecule drug developed by Merck & Company, Inc. (MRK) for hypertension.