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Hydrochlorothiazide

Phase 4FDA approved

Hypertension | Small molecule | Cardiovascular |Novartis AG|Trials Updated: Jun 6, 2011

Hydrochlorothiazide development status

FDA approval on record Mar 6, 1998
Approval holderNovartis
ApplicationNDA020818
Highest phase Phase 4 (NCT00745953)
Phase scored for NVSPhase 3
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

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Hydrochlorothiazide clinical trials

Hydrochlorothiazide · 1 trial · 1 indication

Phase 3 1
NCT00396656Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive PatientsHypertension
COMPLETED30 Analytics
PHASE3COMPLETED
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites
At end of each treatment period (Week 21 and Week 43)

10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.

Secondary Endpoints

Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites
At end of each treatment period (Week 21 and Week 43)
Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites
At end of each treatment period (Week 21 and Week 43)
Mean Post-treatment Microcirculation at NaCl Injected Sites
At end of each treatment period (Week 21 and Week 43)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Valsartan followed by atenolol + hydrochlorothiazide (HCTZ)EXPERIMENTALAfter a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.
Atenolol + hydrochlorothiazide (HCTZ) followed by valsartanEXPERIMENTALAfter a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning. After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning.

Interventions

NameTypeDescription
AtenololDRUG100 mg tablets orally once a day (od) in the morning.
Hydrochlorothiazide (HCTZ))DRUG12.5 or 25 mg tablets orally once a day (od) in the morning.
ValsartanDRUG80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
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Eligibility Criteria

Age Range40 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Caucasian; male or female outpatients and age between 40-65 years of age, inclusive. * At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and \< 110 mmHg. Exclusion Criteria: * If a single reading for arterial hypertension in msSBP...

Countries:GermanySwitzerland
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Frequently asked questions about Hydrochlorothiazide

What is Hydrochlorothiazide used for?

Hydrochlorothiazide is used for hypertension, also known as high blood pressure. It belongs to the cardiovascular therapeutic area and is a small molecule drug. In clinical research it has been studied in hypertensive patients, including a Phase 3 trial comparing valsartan versus atenolol and hydrochlorothiazide combination on blood flow.

What does Hydrochlorothiazide target?

Hydrochlorothiazide targets SLC12A3. It acts as an inhibitor of this target. SLC12A3 is the sodium chloride cotransporter in the distal convoluted tubule of the kidney, and inhibition of this transporter is the mechanism by which hydrochlorothiazide exerts its pharmacological effect.

Who makes Hydrochlorothiazide?

Hydrochlorothiazide is developed by Novartis AG, which trades under the ticker NVS. The company is associated with the clinical development program for this small molecule in hypertension.

What phase is Hydrochlorothiazide in?

Hydrochlorothiazide is in Phase 3 development for hypertension. It is an investigational small molecule and is not stated to be FDA approved. The Phase 3 trial in the program has been completed, and there are currently no active trials listed for this asset.

What clinical trials is Hydrochlorothiazide in?

Hydrochlorothiazide has been studied in one completed Phase 3 trial, NCT00396656, titled Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients. The trial enrolled 30 participants, was randomized and controlled, and was conducted in Germany and Switzerland.

Is Hydrochlorothiazide the same as HCTZ?

Yes, Hydrochlorothiazide is also known as HCTZ. HCTZ is the common abbreviation used for hydrochlorothiazide in clinical and prescribing contexts. Both names refer to the same small molecule drug developed by Novartis AG for hypertension.