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Diovan HCT (Valsartan / Hydrochlorothiazide) - Summary

 



WARNING: AVOID USE IN PREGNANCY

When pregnancy is detected, discontinue Diovan   HCT ® as soon as possible. Drugs that act directly on the renin - angiotensin system can cause injury and even death to the developing fetus . [ See Warnings and Precautions (5.1) ]

 

DIOVAN HCT SUMMARY

WARNING:

Diovan HCT® (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.

Diovan HCT® (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Diovan HCT (Valsartan / Hydrochlorothiazide)

A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.

Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.

Research Indicates Gaps In Care For Diabetes, Cholesterol, Hypertension Among The Uninsured
Source: Cholesterol News From Medical News Today [2009.10.21]
A new study shows uninsured American adults with chronic illnesses like diabetes or high cholesterol often go undiagnosed and undertreated, leading to an increased risk of costly, disabling and even lethal complications of their disease. The study, published online in Health Affairs, analyzed data from a recent national survey conducted by the Centers for Disease Control and Prevention (CDC).

ESC Press Statement: Accelerated Bone Growth May Be An Indicator Of Hypertension In Children
Source: Hypertension News From Medical News Today [2009.10.21]
Children whose bones are "older" than their chronological age may be at an increased risk of hypertension, according to a study reported (19 October) in Hypertension: Journal of the American Heart Association.(1) As a result, the investigators suggest that markers of biological maturity should be evaluated in hypertensive children, and that physical activity and diet may deter the accelerated development of biological maturity.

Clues to Hypertension in Kids May Be Seen in Bones (HealthDay)
Source: Y! Health Bones, Joints & Muscles News [2009.10.20]
HealthDay - TUESDAY, Oct. 20 (HealthDay News) -- New research links high blood pressure in children to bones that are more mature than average, suggesting that advanced bone age may predict cardiovascular problems.

more news >>

Published Studies Related to Diovan HCT (Valsartan / Hydrochlorothiazide)

Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study. [2009.06]
BACKGROUND: Previous studies using the combination of angiotensin-receptor blockers and hydrochlorothiazide (HCTZ) have shown superior ambulatory blood pressure (ABP) reduction in study participants with stage 2 hypertension compared with monotherapy. OBJECTIVE: This multicenter, double-blind, parallel group, forced-titration study of individuals with stage 2 hypertension, compared the efficacy of valsartan and amlodipine in combination with HCTZ on ABP reduction... CONCLUSION: On the basis of ABP monitoring but not office measurements, the fixed-dose combination of valsartan/HCTZ is a significantly more effective treatment regimen than amlodipine/HCTZ, with similar tolerability.

Efficacy and safety of valsartan/hydrochlorothiazide fixed-dose combination compared with amlodipine monotherapy as first-line therapy for mild to moderate hypertension. [2009.03]
This double-blind, active- and randomized-controlled study compared the efficacy and safety of a fixed-dose combination of valsartan/hydrochlorothiazide 80 mg/12.5 mg once daily (n = 32) with amlodipine monotherapy 5 mg once daily (n = 33) for 8 weeks in patients with mild to moderate hypertension...

Randomized, Double-blinded Trial Evaluation of Valsartan/Hydrochlorothiazide Combination Therapy in Mild to Moderate Essential Hypertension in North-east China. [2008.07]
In this randomized, double-blind study, 126 mild to moderate essential hypertensive patients from northern China were studied to determine the efficacy and safety of a combination therapy of valsartan and hydrochlorothiazide. Patients were randomized to the V80/H12.5 (80 mg valsartan/12.5 mg hydrochlorothiazide) group or the V80 (80 mg valsartan) group.

Combination therapy with valsartan/hydrochlorothiazide at doses up to 320/25 mg improves blood pressure levels in patients with hypertension inadequately controlled by valsartan 320 mg monotherapy. [2008.06]
OBJECTIVES: To investigate the efficacy and tolerability of valsartan (Val) 320 mg once daily (o.d.), Val/hydrochlorothiazide (HCTZ) 320/12.5 mg o.d. and Val/HCTZ 320/25 mg o.d. in patients with hypertension not adequately controlled by Val monotherapy... CONCLUSIONS: The combination ofVal and HCTZ at doses of 320/12.5 mg and 320/25 mg increases antihypertensive efficacy in patients with mild-to-moderate hypertension inadequately controlled with Val 320 mg monotherapy, without compromising tolerability.

Combination therapy with valsartan/hydrochlorothiazide at doses up to 320/25 mg improves blood pressure levels in patients with hypertension inadequately controlled by valsartan 320 mg monotherapy. [2008.01.24]
Objectives... The combination of Val and HCTZ at doses of 320/12.5 mg and 320/25 mg increases antihypertensive efficacy in patients with mild-to-moderate hypertension inadequately controlled with Val 320 mg monotherapy, without compromising tolerability.

more studies >>

Clinical Trials Related to Diovan HCT (Valsartan / Hydrochlorothiazide)

A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-Term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. [Active, not recruiting]
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/HCTZ.

A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan. [Completed]
Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o. d. The combination of HCTZ 12. 5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide.

The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12. 5 mg to valsartan 80 mg in those hypertensive patients.

This study is not recruiting in the US.

To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers [Completed]
The purpose of this study is to assess how the body changes the blood level of single dose of valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation under fasting condition in healthy volunteers.

8-Week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension [Completed]
The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects. [Completed]
This study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.

more trials >>

Page last updated: 2009-10-31

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