CLINICAL TRIALS PROFILE FOR NIFEDIPINE

All Clinical Trials for Nifedipine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000102 ↗	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	1969-12-31	This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00000478 ↗	Asymptomatic Cardiac Ischemia Pilot (ACIP) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-11-01	To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.
NCT00000530 ↗	Raynaud's Treatment Study (RTS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1992-09-01	To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.
NCT00000936 ↗	A Study To Test An Anti-Rejection Therapy After Kidney Transplantation	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1999-11-01	Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	Hennepin County Medical Center, Minneapolis	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for Nifedipine

Condition Name

Condition Name for Nifedipine
Intervention	Trials
Hypertension	30
Preterm Labor	10
Hypertension in Pregnancy	10
Preeclampsia	6

Condition MeSH

Condition MeSH for Nifedipine
Intervention	Trials
Hypertension	56
Obstetric Labor, Premature	32
Premature Birth	24
Pre-Eclampsia	22

Clinical Trial Locations for Nifedipine

Trials by Country

Trials by Country for Nifedipine
Location	Trials
United States	96
China	30
United Kingdom	22
Italy	22
Spain	15

Trials by US State

Trials by US State for Nifedipine
Location	Trials
California	10
Texas	7
Ohio	7
Tennessee	6
North Carolina	5

Clinical Trial Progress for Nifedipine

Clinical Trial Phase

Clinical Trial Phase for Nifedipine
Clinical Trial Phase	Trials
Phase 4	50
Phase 3	26
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for Nifedipine
Clinical Trial Phase	Trials
Completed	82
Unknown status	32
Recruiting	20

Clinical Trial Sponsors for Nifedipine

Sponsor Name

Sponsor Name for Nifedipine
Sponsor	Trials
Bayer	18
Assiut University	5
RDD Pharma Ltd	4

Sponsor Type

Sponsor Type for Nifedipine
Sponsor	Trials
Other	171
Industry	42
NIH	7

Nifedipine: Clinical Trials, Market Analysis, and Projections

Introduction to Nifedipine

Nifedipine is a calcium channel blocker widely used to treat various cardiovascular conditions, including hypertension, angina, and preterm labor. Its efficacy and safety have been the focus of several clinical trials and market analyses.

Clinical Trials Update

Intrapartum Extended-Release Nifedipine for Preeclampsia

A recent randomized, triple-blind, placebo-controlled trial investigated the use of extended-release nifedipine in individuals with preeclampsia undergoing labor induction. The study found that nifedipine significantly reduced the need for acute hypertensive therapy compared to the placebo group. Specifically, 34.0% of the nifedipine group required acute treatment versus 55.1% of the placebo group, with a relative risk of 0.62 (95% CI, 0.39–0.97)[1].

Key outcomes included:

• Reduced Need for Acute Hypertensive Therapy: The number needed to treat to prevent receipt of acute treatment was 4.7 (95% CI, 2.5–44.3).
• Lower Cesarean Delivery Rates: Fewer individuals in the nifedipine group required cesarean delivery (20.8% vs 34.7% in the placebo group).
• Lower Neonatal Intensive Care Unit Admission: The nifedipine group had a lower rate of neonatal intensive care unit admission (29.1% vs 47.1% in the placebo group)[1].

Comparison with Labetalol in Pregnancy

Another study, a secondary analysis of the CHAP (Chronic Hypertension in Pregnancy) trial, compared maternal and neonatal outcomes between labetalol and nifedipine in pregnant patients with mild chronic hypertension. The analysis found no significant differences in predetermined maternal or neonatal outcomes between the two groups. Both labetalol and nifedipine reduced the risk of the primary outcome (superimposed preeclampsia with severe features, preterm birth before 35 weeks, placental abruption, or fetal or neonatal death) compared to standard care, but there was no significant difference when labetalol was compared directly with nifedipine[4].

Market Analysis

Market Size and Growth

The global nifedipine market is projected to experience significant growth. By 2027, the market size is estimated to reach $1.7 billion, growing at a CAGR of 4.1% from 2022 to 2027[2].

• Current Market Size: As of 2023, the global nifedipine market was valued at $824.3 million and is expected to grow to $1,661.5 million by 2032 at a CAGR of 8.1%[3].
• Forecasted Growth: By 2032, the market is projected to reach $2,254.9 million, with a CAGR of 8.4% from 2020 to 2032[5].

Geographical Segmentation

The nifedipine market is segmented geographically, with different regions showing varying growth rates:

• North America: This region holds the largest market share, driven by high rates of obesity and associated health issues such as hypertension and cardiovascular diseases. The region is expected to grow at a CAGR of 8.5% during the forecast period[5].
• Asia-Pacific: This region is anticipated to be the fastest-growing segment, with a CAGR of 8.8% due to expanding healthcare infrastructure, increasing telemedicine adoption, and government initiatives to improve healthcare access[5].

Market Drivers

Several factors are driving the growth of the nifedipine market:

• Increasing Prevalence of Cardiovascular Diseases: The rising global incidence of hypertension and angina is a primary driver for the nifedipine market[3].
• Technological Advancements: Improved formulations and enhanced drug delivery systems contribute to increased efficacy and patient compliance[3].
• Growing Aging Population: The demographic shift towards an aging population increases the demand for medications like nifedipine[3].
• Expansion of Healthcare Infrastructure: Improvements in healthcare infrastructure in emerging markets increase access to medications[3].
• Telehealth and Digital Health Integration: The increasing acceptance of telehealth services enhances patient access, especially in regions with limited healthcare infrastructure[3].

Market Challenges

Despite the growth, the nifedipine market faces some challenges:

• Side Effects: Health concerns linked to nifedipine, such as potential hypotension and other adverse effects, can hamper market growth[2].
• Generic Competition: The presence of generic alternatives can impact the market share of branded nifedipine products[3].

Projections and Future Outlook

Market Size Projections

By 2032, the global nifedipine market is expected to reach $2,254.9 million, with a significant increase from the current market size. This growth is driven by the increasing prevalence of cardiovascular diseases, technological advancements, and the expansion of healthcare infrastructure in emerging markets[5].

Regional Growth

• North America: Expected to continue as the largest market shareholder, driven by chronic health issues and advanced healthcare infrastructure[5].
• Asia-Pacific: Poised to be the fastest-growing region due to government initiatives, expanding healthcare infrastructure, and increasing telemedicine adoption[5].

Innovations and Trends

• Personalized Medicine: The trend towards personalized medicine is expected to open opportunities for tailored treatments, leading to better outcomes and patient satisfaction[3].
• Digital Health Integration: The integration of telehealth services and digital health solutions will continue to enhance patient access and compliance[3].

Key Takeaways

• Clinical Efficacy: Nifedipine has shown efficacy in reducing acute hypertensive therapy in preeclampsia and is comparable to labetalol in managing chronic hypertension in pregnancy.
• Market Growth: The global nifedipine market is projected to grow significantly, driven by increasing cardiovascular diseases, technological advancements, and expanding healthcare infrastructure.
• Geographical Focus: North America and Asia-Pacific are key regions, with North America holding the largest market share and Asia-Pacific expected to be the fastest-growing segment.
• Challenges: Despite growth, the market faces challenges such as side effects and generic competition.

FAQs

What is the primary use of nifedipine in clinical settings?

Nifedipine is primarily used to treat hypertension, angina, and preterm labor, and it has also been studied for its efficacy in managing preeclampsia during labor.

How does nifedipine compare to labetalol in pregnancy?

Nifedipine and labetalol have similar efficacy in managing chronic hypertension in pregnancy, with no significant differences in maternal or neonatal outcomes between the two groups[4].

What are the key drivers of the nifedipine market?

The key drivers include the increasing prevalence of cardiovascular diseases, technological advancements in drug formulations, the growing aging population, and the expansion of healthcare infrastructure in emerging markets[3].

Which region is expected to be the fastest-growing segment for the nifedipine market?

The Asia-Pacific region is anticipated to be the fastest-growing segment, driven by expanding healthcare infrastructure, increasing telemedicine adoption, and government initiatives to improve healthcare access[5].

What challenges does the nifedipine market face?

The market faces challenges such as health concerns linked to nifedipine, including potential side effects, and competition from generic alternatives[2][3].

Sources

1. Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension in Preeclampsia. American Heart Association Journals.
2. Nifedipine Market Size Report, 2022-2027. IndustryARC.
3. Global Nifedipine Market Size, Trends, Share, Forecast 2032. Custom Market Insights.
4. Pregnancy Outcomes of Nifedipine Compared With Labetalol for Chronic Hypertension. PubMed.
5. Nifedipine Market Size, Share, Trends, Forecast Report 2032. Straits Research.