CLINICAL TRIALS PROFILE FOR DIOVAN HCT

All Clinical Trials for Diovan Hct

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	Bayer	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	GlaxoSmithKline	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	Boehringer Ingelheim	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00130156 ↗	Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension	Completed	Eisai Co., Ltd.	Phase 4	2005-10-01	The purpose of this study is to investigate the efficacy and safety of Bunazosin with Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential hypertension accompanied by metabolic syndrome.
NCT00130156 ↗	Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension	Completed	Eisai Inc.	Phase 4	2005-10-01	The purpose of this study is to investigate the efficacy and safety of Bunazosin with Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential hypertension accompanied by metabolic syndrome.

Clinical Trial Conditions for Diovan Hct

Condition Name

Condition Name for Diovan Hct
Intervention	Trials
Hypertension	22
High Blood Pressure	3
Heart Failure	2
Essential Hypertension	2

Condition MeSH

Condition MeSH for Diovan Hct
Intervention	Trials
Hypertension	25
Essential Hypertension	6
Diabetes Mellitus	6
Diabetes Mellitus, Type 2	5

Clinical Trial Locations for Diovan Hct

Trials by Country

Trials by Country for Diovan Hct
Location	Trials
United States	155
Korea, Republic of	10
China	8
Canada	7
Japan	6

Trials by US State

Trials by US State for Diovan Hct
Location	Trials
Pennsylvania	7
Maryland	7
New York	7
Texas	6
Missouri	6

Clinical Trial Progress for Diovan Hct

Clinical Trial Phase

Clinical Trial Phase for Diovan Hct
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	10
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Diovan Hct
Clinical Trial Phase	Trials
Completed	31
Unknown status	6
Terminated	6

Clinical Trial Sponsors for Diovan Hct

Sponsor Name

Sponsor Name for Diovan Hct
Sponsor	Trials
Novartis	7
Boryung Pharmaceutical Co., Ltd	4
Novartis Pharmaceuticals	4

Sponsor Type

Sponsor Type for Diovan Hct
Sponsor	Trials
Other	65
Industry	35
NIH	4

DIOVAN HCT: Clinical Trials, Market Analysis, and Projections

Introduction

DIOVAN HCT, a combination medication of valsartan and hydrochlorothiazide, has been a significant player in the treatment of hypertension. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Approval and Indications

DIOVAN HCT was approved by the FDA in 1998 for the treatment of hypertension and later approved as a first-line treatment in 2008. It is indicated for patients who are not adequately controlled with monotherapy and for those likely to need multiple drugs to achieve their blood pressure goals[2][4].

Clinical Trial Outcomes

Clinical trials have demonstrated the efficacy and tolerability of DIOVAN HCT. Studies involving approximately 2,000 patients showed that DIOVAN HCT significantly improved blood pressure control compared to monotherapy with either valsartan or hydrochlorothiazide. For instance, patients with a baseline blood pressure of 160/100 mmHg had an 84% likelihood of achieving a systolic blood pressure of <140 mmHg and an 80% likelihood of achieving a diastolic blood pressure of <90 mmHg when treated with DIOVAN HCT, compared to 41% and 60% with valsartan alone, respectively[1][4].

Safety Profile

The safety profile of DIOVAN HCT has been evaluated in over 5,700 patients, including those treated for more than six months and over a year. Adverse reactions were generally mild and transient, with the most common reasons for discontinuation being headache and dizziness. The overall incidence of adverse reactions was comparable to placebo, and discontinuation due to side effects was required in only 2.3% of patients[1][4].

Market Analysis

Market Position

DIOVAN HCT has been one of the top-selling drugs in the cardiovascular segment. In 2013, it generated total sales of $3,524 million, highlighting its significant market presence[5].

Regional Market

Geographically, the global diuretics agents market, which includes DIOVAN HCT, is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Asia Pacific and North America held leading shares of the market in 2016 and are expected to retain their positions until 2025. The rising prevalence of hypertensive complications, increasing government initiatives, and growing awareness among patients are key drivers in these regions[5].

Competitive Landscape

The diuretics agents market is competitive, with other key drugs such as Benicar HCT (olmesartan and hydrochlorothiazide), Exforge HCT (amlodipine, hydrochlorothiazide, and valsartan), Hyzaar (losartan and hydrochlorothiazide), and Micardis (telmisartan). The loss of patents for some of these drugs, such as Benicar HCT and Exforge HCT, has opened up opportunities for generic competition, which could impact the market share of DIOVAN HCT[5].

Market Projections

Growth Drivers

The global diuretics agents market, including DIOVAN HCT, is expected to grow driven by several factors:

• Rising Prevalence of Hypertension: High blood pressure affects approximately 73 million adult Americans and one in four adults worldwide, making it a significant public health issue[2].
• Increasing Government Initiatives: Governments are implementing policies to reduce the period of patent exclusivity for new drug applications, which could lead to more affordable treatments and increased market penetration[5].
• Growing Awareness and Disposable Income: In regions like Asia Pacific, growing awareness among patients and increasing disposable income are propelling the market forward[5].

Challenges

Despite the growth drivers, the market faces several challenges:

• Generic Competition: The expiration of patents for similar drugs could lead to increased generic competition, potentially reducing the market share of DIOVAN HCT[5].
• Regulatory Actions: Unexpected regulatory actions or delays can impact the sales and revenue projections of DIOVAN HCT[2].

Key Takeaways

• Clinical Efficacy: DIOVAN HCT has demonstrated significant efficacy in controlling blood pressure, especially in patients who require multiple medications.
• Market Presence: It remains a top-selling drug in the cardiovascular segment, with a strong market position globally.
• Growth Prospects: The market is expected to grow driven by the rising prevalence of hypertension, government initiatives, and increasing patient awareness.
• Challenges: The market faces challenges from generic competition and potential regulatory actions.

FAQs

What is DIOVAN HCT used for?

DIOVAN HCT is used for the treatment of hypertension, particularly in patients who are not adequately controlled with monotherapy or those likely to need multiple drugs to achieve their blood pressure goals[4].

What are the common side effects of DIOVAN HCT?

Common side effects include headache, dizziness, nasopharyngitis, and upper respiratory infections. These adverse reactions are generally mild and transient[1][4].

How does DIOVAN HCT compare to monotherapy in clinical trials?

Clinical trials have shown that DIOVAN HCT significantly improves blood pressure control compared to monotherapy with either valsartan or hydrochlorothiazide alone[1][4].

What regions are expected to drive the growth of the diuretics agents market?

Asia Pacific and North America are expected to retain their leading shares of the market until 2025, driven by the rising prevalence of hypertensive complications and increasing government initiatives[5].

What are the potential challenges for DIOVAN HCT in the market?

The potential challenges include generic competition due to the expiration of patents for similar drugs and unexpected regulatory actions or delays[2][5].

Sources

1. Novartis - DIOVAN HCT [PDF]
2. Fierce Biotech - Diovan HCT and Exforge Approved in US as First-Line Treatments
3. FDA - 21-283/S-024 - Diovan for the treatment of hypertension in pediatric patients
4. FDA - Diovan HCT (hydrochlorothiazide and valsartan) tablet label [PDF]
5. BioSpace - Diuretic Agents Market: Rise in the number of hypertensive patients to drive the market