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HCTZ monotherapy

Phase 3

Hypertension | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Apr 15, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment496

FDA Designations

No designations recorded

Clinical trial landscape

HCTZ monotherapy · 1 trial · 1 indication

Phase 3 1
NCT00095550Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate HypertensionHypertension
COMPLETED496 Analytics
PHASE3COMPLETED
Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in SeSBP at Week 8

Secondary Endpoints

Frequency of discontinuation due to AE, frequencies of hypotension, dizziness, syncope, headaches, hypokalemia and hyperkalemia after 12 weeks of therapy.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1EXPERIMENTAL -
A2ACTIVE_COMPARATOR -
A3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Irbesartan/HCTZDRUGTablets, Oral, Irbesartan 150 mg/HCTZ 12.5 mg, Once daily, 12 weeks.
Irbesartan monotherapyDRUGTablets, Oral, 150 mg, Once daily, 12 weeks.
HCTZ monotherapyDRUGTablets, Oral, 12.5 mg, Once daily, 12 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: * Willing to provide written informed consent * Subjects must have uncontrolled hypertension defined as: * average systolic blood pressure between 160 mmHg and 180 mmHg (while diastolic blood pressure is less than 110 mmHg) or * average diastolic blood pressure between 100 ...

Countries:United StatesCanadaFranceGermanyRussia
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Frequently asked questions about HCTZ monotherapy

What is HCTZ monotherapy used for?

HCTZ monotherapy is used for the treatment of hypertension, a condition of persistently elevated blood pressure. It is a small molecule drug being developed by Bristol-Myers Squibb Company for this cardiovascular indication.

What does HCTZ monotherapy target?

HCTZ monotherapy is a thiazide diuretic that works by inhibiting sodium reabsorption in the distal convoluted tubule of the kidney, promoting water and electrolyte excretion, which lowers blood pressure. This mechanism is well-established for hydrochlorothiazide.

Who makes HCTZ monotherapy?

HCTZ monotherapy is being developed by Bristol-Myers Squibb Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is HCTZ monotherapy in?

HCTZ monotherapy has completed a Phase 3 clinical trial for hypertension. The trial, NCT00095550, was a randomized, double-blind, active-controlled study that has been completed, indicating the drug is in late-stage clinical development.

What clinical trials is HCTZ monotherapy in?

HCTZ monotherapy has one completed Phase 3 clinical trial, NCT00095550, titled 'Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy for Patients With Moderate Hypertension.' This trial enrolled 496 participants across the United States, Canada, France, Germany, and Russia.

Is HCTZ monotherapy the same as hydrochlorothiazide?

HCTZ monotherapy refers to the use of hydrochlorothiazide as a single agent. The trial NCT00095550 studied this monotherapy in comparison to combination therapy with irbesartan, but the drug itself is the well-known thiazide diuretic hydrochlorothiazide.