CLINICAL TRIALS PROFILE FOR NISOLDIPINE

All Clinical Trials for Nisoldipine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00311870 ↗	Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy	Completed	Bayer	Phase 4	1993-03-01	The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months
NCT00311870 ↗	Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy	Completed	Steno Diabetes Center	Phase 4	1993-03-01	The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months
NCT00311870 ↗	Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy	Completed	Steno Diabetes Center Copenhagen	Phase 4	1993-03-01	The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months
NCT00730197 ↗	Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg	Completed	Mylan Pharmaceuticals	Phase 1	2007-02-01	The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fasting conditions.
NCT00979537 ↗	Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers	Completed	Mylan Pharmaceuticals	Phase 1	2007-03-01	The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fed conditions.
NCT00985660 ↗	Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg	Completed	Mylan Pharmaceuticals	Phase 1	2007-06-01	The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg tablet) dose administration in healthy adult subjects under fasting conditions.
NCT05279807 ↗	Effectiveness and Safety of Combination of Amlodipine and Zofenopril in Hypertensive Patients Versus Each Monotherapy	Recruiting	Menarini International Operations Luxembourg SA	Phase 4	2021-10-15	Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Zofenopril 30 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment in patients with uncontrolled BP previously treated with Zofenopril or Amlodipine (5 mg) monotherapies for at least 4 weeks.

Clinical Trial Conditions for Nisoldipine

Condition Name

Condition Name for Nisoldipine
Intervention	Trials
Healthy	3
Hypertension	2
Diabetic Nephropathy	1

Condition MeSH

Condition MeSH for Nisoldipine
Intervention	Trials
Hypertension	2
Kidney Diseases	1
Diabetic Nephropathies	1

Clinical Trial Locations for Nisoldipine

Trials by Country

Trials by Country for Nisoldipine
Location	Trials
United States	3
Denmark	1
Bulgaria	1
Hungary	1

Trials by US State

Trials by US State for Nisoldipine
Location	Trials
North Dakota	3

Clinical Trial Progress for Nisoldipine

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Nisoldipine
Clinical Trial Phase	Trials
Completed	4
Recruiting	2

Clinical Trial Sponsors for Nisoldipine

Sponsor Name

Sponsor Name for Nisoldipine
Sponsor	Trials
Mylan Pharmaceuticals	3
Menarini International Operations Luxembourg SA	2
Bayer	1

Sponsor Type

Sponsor Type for Nisoldipine
Sponsor	Trials
Industry	6
Other	2

Nisoldipine: Clinical Trials, Market Analysis, and Projections

Introduction to Nisoldipine

Nisoldipine is a potent 1,4-dihydropyridine calcium channel antagonist, commonly used in the treatment of hypertension and angina pectoris. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Efficacy in Angina Pectoris

A significant clinical trial investigated the efficacy of nisoldipine in patients with stable angina pectoris. This double-blind, dose-response, placebo-controlled multicenter study involved 231 patients who were randomized into four treatment groups: placebo, nisoldipine 2.5 mg, nisoldipine 5 mg, and nisoldipine 10 mg, all administered twice daily for 4 weeks[1].

• The results showed that nisoldipine did not significantly outperform placebo in treating angina pectoris. While there were marginal trends toward increases in time to onset of angina and total exercise time at peak effect (2 hours after the dose), these effects were not sustained at trough levels (10-14 hours after the dose).
• A subset analysis of patients with severe angina during the placebo phase showed some benefits with the 5 mg and 10 mg doses, but these were not consistent across all parameters.
• The frequency of anginal attacks decreased similarly across all groups, including the placebo group, indicating no significant advantage of nisoldipine over placebo.

Safety and Adverse Events

The same study highlighted that nisoldipine therapy was associated with a higher incidence of serious adverse events. Four patients developed unstable angina, and two patients died suddenly in the 10 mg twice-daily group[1].

Use in Hypertension

Nisoldipine has been extensively used in clinical trials for the treatment of hypertension. More than 6,000 patients worldwide have received nisoldipine in various clinical trials, with the drug generally being well-tolerated. However, adverse events related to its vasodilator properties, such as edema and dizziness, were common and led to treatment discontinuation in some cases[5].

Market Analysis

Global Market Size and Growth

The global nisoldipine market is part of the broader calcium channel blocker market. As of 2021, the market size was estimated to be significant, though exact figures are not provided in the available sources. The market is projected to grow at a moderate CAGR during the forecast period from 2022 to 2028[2][3].

Market Segmentation

The nisoldipine market is segmented by type and application:

• Type: The market is divided into 98% purity and 99% purity segments.
• Application: The primary applications are antihypertensive drugs, organic synthesis, and other uses[2].

Regional Analysis

The market is analyzed across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. The Asia-Pacific region is expected to be a significant growth area due to increasing chronic diseases and improving healthcare infrastructure[2][3].

Key Market Players

Major players in the nisoldipine market include Jinan Kehui Pharmaceutical Technology, Shandong Keyuan Pharmaceutical, and AdvaCare Pharma. These companies hold a substantial share of the global market and are key drivers of market growth[2].

Market Projections

Growth Drivers

• Increasing Prevalence of Hypertension and Cardiovascular Diseases: The rising incidence of hypertension and other cardiovascular diseases is a major driver for the nisoldipine market. These conditions are becoming more prevalent due to factors such as obesity, high cholesterol, and poor lifestyle choices[4].
• Advancements in Healthcare Infrastructure: Improving healthcare infrastructure, especially in Asia-Pacific regions, is expected to boost the demand for nisoldipine and other calcium channel blockers[2].

Market Challenges

• Side Effects and Adverse Events: The drug's side effects, such as edema, dizziness, and the potential for serious adverse events like unstable angina and sudden death, can hamper market growth[1][5].
• Competition from Other Calcium Channel Blockers: The market for calcium channel blockers is competitive, with other drugs like nifedipine also being widely used. This competition can impact the growth of the nisoldipine market[4].

Key Takeaways

• Clinical Efficacy: Nisoldipine has shown limited superiority over placebo in treating angina pectoris but is effective in managing hypertension.
• Market Growth: The global nisoldipine market is expected to grow moderately, driven by increasing prevalence of hypertension and cardiovascular diseases.
• Regional Focus: The Asia-Pacific region is anticipated to be a key growth area due to improving healthcare infrastructure and rising chronic diseases.
• Challenges: The market faces challenges from side effects and competition from other calcium channel blockers.

FAQs

What is nisoldipine used for?

Nisoldipine is primarily used for the treatment of hypertension and angina pectoris.

What were the findings of the clinical trial on nisoldipine for angina pectoris?

The clinical trial found that nisoldipine did not significantly outperform placebo in treating angina pectoris, with only marginal benefits at peak effect and no sustained benefits at trough levels.

What are the common side effects of nisoldipine?

Common side effects include edema, dizziness, and other vasodilator-related adverse events. Serious adverse events such as unstable angina and sudden death have also been reported.

Who are the key players in the nisoldipine market?

Key players include Jinan Kehui Pharmaceutical Technology, Shandong Keyuan Pharmaceutical, and AdvaCare Pharma.

What is the projected growth of the nisoldipine market?

The market is expected to grow at a moderate CAGR during the forecast period from 2022 to 2028, driven by increasing prevalence of hypertension and cardiovascular diseases.

What regions are expected to drive the growth of the nisoldipine market?

The Asia-Pacific region is expected to be a significant growth area due to improving healthcare infrastructure and rising chronic diseases.

Sources

1. Double-blind, dose-response, placebo-controlled multicenter study: PubMed, "Monotherapy with 2.5, 5, and 10 mg nisoldipine twice a day was not superior to placebo therapy in treating patients with angina pectoris."
2. Nisoldipine Market Report: OpenPR, "Nisoldipine Market Report- Statistical Analysis, Business Opportunity and Forecast 2025."
3. Nisoldipine Market Size, Share, Trend and Forecast: Prof Research, "Nisoldipine Market Size, Share, Trend and Forecast to 2025."
4. Nifedipine Market Size Report: IndustryARC, "Nifedipine Market Size Report, 2022-2027."
5. SULAR (nisoldipine) Label: FDA, "SULAR (nisoldipine) - accessdata.fda.gov."