CLINICAL TRIALS PROFILE FOR BENDROFLUMETHIAZIDE

All Clinical Trials for BENDROFLUMETHIAZIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00320879 ↗	Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria	Completed	Steno Diabetes Center	Phase 4	2003-09-01	Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg o.d. for the entire study. Following two months wash-out (baseline), patients will be treated randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).
NCT00320879 ↗	Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria	Completed	Steno Diabetes Center Copenhagen	Phase 4	2003-09-01	Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg o.d. for the entire study. Following two months wash-out (baseline), patients will be treated randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).
NCT00647660 ↗	Fasting Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2006-07-01	The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fasting conditions.
NCT00648297 ↗	Fed Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2006-08-01	The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose administered under fed conditions.

Clinical Trial Conditions for BENDROFLUMETHIAZIDE

Condition Name

Condition Name for BENDROFLUMETHIAZIDE
Intervention	Trials
Healthy	2
Heart Failure	1
Microalbuminuria	1
Type 2 Diabetes	1

Condition MeSH

Condition MeSH for BENDROFLUMETHIAZIDE
Intervention	Trials
Heart Failure	1
Albuminuria	1

Clinical Trial Locations for BENDROFLUMETHIAZIDE

Trials by Country

Trials by Country for BENDROFLUMETHIAZIDE
Location	Trials
United States	2
Denmark	1

Trials by US State

Trials by US State for BENDROFLUMETHIAZIDE
Location	Trials
North Dakota	2

Clinical Trial Progress for BENDROFLUMETHIAZIDE

Clinical Trial Phase

Clinical Trial Phase for BENDROFLUMETHIAZIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for BENDROFLUMETHIAZIDE
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for BENDROFLUMETHIAZIDE

Sponsor Name

Sponsor Name for BENDROFLUMETHIAZIDE
Sponsor	Trials
Mylan Pharmaceuticals	2
Steno Diabetes Center	1
Steno Diabetes Center Copenhagen	1

Sponsor Type

Sponsor Type for BENDROFLUMETHIAZIDE
Sponsor	Trials
Other	3
Industry	2

BENDROFLUMETHIAZIDE Market Analysis and Financial Projection

Bendroflumethiazide: Clinical Trials, Market Analysis, and Projections

Introduction to Bendroflumethiazide

Bendroflumethiazide, a thiazide diuretic, is widely used in the management of hypertension and edema. It works by increasing the excretion of sodium and water, thereby reducing blood pressure. Here, we will delve into recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials: Efficacy and Safety

Low-Dose Bendroflumethiazide Studies

Several clinical trials have evaluated the efficacy and safety of low-dose bendroflumethiazide. A randomized, double-blind, placebo-controlled crossover study found that 1.25 mg of bendroflumethiazide daily significantly lowered 24-hour blood pressure averages compared to placebo. The study reported a reduction in systolic blood pressure from 136 mmHg to 125 mmHg and in diastolic blood pressure from 85 mmHg to 78 mmHg[2].

Another multicenter study compared the efficacy and safety of bendroflumethiazide at doses of 1.25 mg and 2.5 mg per day, combined with potassium chloride, against other antihypertensive agents like amlodipine and enalapril. The results showed that all treatments significantly reduced diastolic blood pressure, with bendroflumethiazide 1.25 mg/day reducing it by 6.8 mmHg and 2.5 mg/day by 9.1 mmHg. The study also noted that bendroflumethiazide was well-tolerated and did not significantly affect heart rate, serum potassium, blood glucose, or serum cholesterol levels[4].

Combination Therapies

A comparative study in Tanzania evaluated the blood pressure lowering effect of bendroflumethiazide in combination with either amlodipine or lisinopril. The study found that both combinations significantly reduced blood pressure after 4 weeks of treatment, with a mean reduction of 43/22 mmHg in the amlodipine group and 40/22 mmHg in the lisinopril group. The majority of patients (85.4%) achieved blood pressure control by the end of the study[5].

Market Analysis

Current Market Trends

The generic drugs market, which includes bendroflumethiazide, has seen significant growth. By 2015, generic drugs accounted for nearly $350 billion in revenue and were expected to grow at a CAGR of 12% over the next five years[3].

Bendroflumethiazide, being a generic medication, benefits from this trend. Its affordability and efficacy make it a popular choice for managing hypertension, especially in regions where cost is a significant factor.

Competitive Landscape

The antihypertensive market is highly competitive, with various classes of drugs such as ACE inhibitors (e.g., enalapril), calcium channel blockers (e.g., amlodipine), and diuretics (e.g., bendroflumethiazide). However, bendroflumethiazide remains a viable option due to its proven efficacy and safety profile, particularly at low doses.

Projections and Future Outlook

Market Growth

Given the increasing prevalence of hypertension globally, the demand for antihypertensive medications is expected to rise. Bendroflumethiazide, with its established track record and cost-effectiveness, is likely to continue playing a significant role in this market.

Emerging Markets

In developing countries, where access to healthcare and affordability are critical, bendroflumethiazide is poised to see increased adoption. Studies like the one conducted in Tanzania highlight the drug's potential in such regions[5].

Regulatory and Healthcare Trends

Regulatory environments that favor the use of generic medications will continue to support the growth of bendroflumethiazide. Additionally, healthcare policies emphasizing cost-effective treatments will further boost its market presence.

Key Takeaways

• Efficacy: Low-dose bendroflumethiazide has been shown to effectively lower blood pressure over 24 hours without adverse effects on insulin sensitivity or other biochemical parameters.
• Safety: Clinical trials indicate that bendroflumethiazide is well-tolerated, with minimal adverse events compared to other antihypertensive agents.
• Market Trends: The generic drugs market, including bendroflumethiazide, is expected to grow significantly due to its affordability and efficacy.
• Future Outlook: Bendroflumethiazide is likely to remain a key player in the antihypertensive market, especially in emerging markets and regions where cost is a critical factor.

FAQs

What is bendroflumethiazide used for?

Bendroflumethiazide is primarily used to treat hypertension (high blood pressure) and edema (swelling caused by excess fluid).

How does bendroflumethiazide work?

Bendroflumethiazide works by increasing the excretion of sodium and water, which helps reduce blood pressure.

What are the common side effects of bendroflumethiazide?

Common side effects include increased urination, dizziness, and potential changes in serum potassium levels. However, low-dose regimens have been shown to minimize these effects.

Can bendroflumethiazide be used in combination with other medications?

Yes, bendroflumethiazide can be used in combination with other antihypertensive medications like amlodipine and lisinopril, as shown in several clinical trials.

Is bendroflumethiazide available as a generic medication?

Yes, bendroflumethiazide is available as a generic medication, which makes it more affordable and accessible.

Sources

1. *Low dose bendrofluazide (1.25 mg) effectively lowers blood pressure over 24 h: Results of a randomized, double-blind, placebo-controlled crossover study.** American Journal of Hypertension, 12(5), 528–531.
2. *Low dose bendrofluazide (1.25 mg) effectively lowers blood pressure over 24 h: Results of a randomized, double-blind, placebo-controlled crossover study.** American Journal of Hypertension, 12(5), 528–531.
3. Generic Drugs Market Analysis to 2030 With Strategies of 130 Companies Including Generic and Innovator Drug Manufacturers. PR Newswire.
4. Efficacy and safety of 24 weeks of therapy with bendroflumethiazide 1.25 mg/day or 2.5 mg/day and potassium chloride compared with enalapril 10 mg/day and amlodipine 5 mg/day in patients with mild to moderate primary hypertension. PubMed.
5. Amlodipine or Lisinopril in Combination with Bendroflumethiazide in Adult Hypertensive Patients: A Comparative Study. Journal of Hypertension and Management.