The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability of Patients With Grade 1 Hypertension Compared With Nitrendipine or Atenolol Monotherapy.

Study name: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.
Medicine: Nitrendipine/Atenolol; Nitrendipine; Atenolol.
Rationale: Blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. Nitrendipine/Atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown.
Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Study design: This study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: Nitrendipine/Atenolol (5mg/10mg); Nitrendipine (10mg) or atenolol (25mg).
Study population: Men and Women aged 30-65 years (n=32) meeting the inclusion/exclusion criteria.
Randomization and cross-over design: Eligible patients will be randomly divided into two groups. Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.
Follow up: 14 weeks.
Sample size: a total of 32 patients should be enrolled.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.

Start Date27 Sep 2021

Sponsor / Collaborator

Shanghai Jiao Tong University

CTR20210720 / CompletedNot Applicable

尼群地平片（10 mg）人体生物等效性研究

[Translation] Bioequivalence study of nitrendipine tablets (10 mg) in humans

以特一药业集团股份有限公司研制的尼群地平片（规格：10mg）为受试制剂，Bayer Vital GmbH生产的尼群地平片（商品名：Baylotensin，规格：10mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

The nitrendipine tablets (specification: 10 mg) developed by Teyi Pharmaceutical Group Co., Ltd. were used as the test preparation, and the nitrendipine tablets (trade name: Baylotensin, specification: 10 mg) produced by Bayer Vital GmbH were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date18 Apr 2021

Sponsor / Collaborator

Teyi Pharmaceutical Group Co., Ltd.

NCT02217852 / Unknown statusPhase 4IIT

A Randomized, Open-label, Positive Drug Controlled Clinical Trials to Compare the Efficacy of Nitrendipine and Hydrochlorothiazide , Captopril Plus Hydrochlorothiazide and Beijing Hypotensive No.0 in Tibetan Hypertension

Several surveys had revealed that Tibetan adults had high prevalence of hypertension. However, there was no research studying the antihypertensive effect of the known drugs in Tibetan. The main arms of our study were to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between nitrendipine and Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between captopril plus Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.

Start Date01 Aug 2014

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Nitrendipine

100 Translational Medicine associated with Nitrendipine

100 Patents (Medical) associated with Nitrendipine

2,618

Literatures (Medical) associated with Nitrendipine

01 Nov 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Enhanced drug release through nitrendipine/hydroxypropyl methylcellulose solid dispersion via supercritical antisolvent technique

Article

Author: Zhu, Ning ; Hao, Jianxia ; Hong, Hailong ; Song, Lijun

The poor water solubility of nitrendipine (NT) results in low oral bioavailability, which hinders its practical application. Hydroxypropyl methylcellulose (HPMC) is a prominent drug carrier that has been applied in the biomedical field due to its significant characteristics, such as large surface area, biocompatibility and biodegradability. In this study, an efficient drug delivery system based on the preparation of NT/HPMC solid dispersion using supercritical antisolvent (SAS) technology was proposed. The effect of different operating parameters such as solvent, host guest ratio, concentration, temperature, and pressure on NT/HPMC was optimized to obtain dispersed particles with maximum solubility. The formed solid dispersion presents non-static spherical particles with a high surface area and small particle size. Importantly, in vitro drug release studies have demonstrated that the dissolution and solubility of NT in solid dispersion are significantly enhanced compared to pure drug. In vitro bioactivity experiments showed that the NT/HPMC solid dispersion has good biocompatibility and antibacterial performance. Thus, this study indicates that solid dispersion prepared using SAS technology are considered a promising drug delivery system.

01 Nov 2024·CURRENT DRUG METABOLISM

Carboxylesterase 1-Based Drug-Drug Interaction Potential of Remimazolam: In-Vitro Studies and Literature Review

Review

Author: Stohr, Thomas ; Petersen, Karl-Uwe ; Schmalix, Wolfgang ; Pesic, Marija

Background::

The ultra-short-acting benzodiazepine remimazolam, approved for procedural sedation and general anesthesia, is inactivated by carboxylesterase 1 (CES1).

Objective::

Remimazolam´s involvement in CES1-mediated drug-drug interactions (DDIs) was investigated.

Methods::

Possible interactions of remimazolam were studied in co-exposure experiments with eleven different drugs. Further, substrates and inhibitors of CES1, identified in the literature, were evaluated for possible in-vivo inhibition using pharmacokinetic and Ki or IC50 values. Compounds with only one published inhibitory concentration and CES1 substrates lacking inhibition data were assigned conservative Ki values.

Results::

In human liver homogenates and/or blood cells, remimazolam showed no significant inhibition of esmolol and landiolol metabolism, which, in turn, at up to 98 and 169 μM, respectively, did not inhibit remimazolam hydrolysis by human liver homogenates. In human liver S9 fractions, IC50 values ranged from 0.69 μM (simvastatin) and 57 μM (diltiazem) to > 100 μM (atorvastatin) and, for the remaining test items (bupropion, carvedilol, nelfinavir, nitrendipine, and telmisartan), they ranged from 126 to 658 μM. Remifentanil was ineffective even at 1250 μM. Guidance-conforming evaluation revealed no relevant drug-drug interactions with remimazolam via CES1. The algorithm-based predictions were consistent with human study data. Among CES1 inhibitors and substrates identified in the literature, only dapsone and rufinamide were found to be possible in-vivo inhibitors of remimazolam metabolism.

Conclusion::

Data and analyses suggest a very low potential of remimazolam for pharmacokinetic DDIs mediated by CES1. The theoretical approach and compiled data are not specific to remimazolam and, hence, applicable in the evaluation of other CES1 substrates.

14 Jun 2024·MEDICINE

A network meta-analysis comparative the efficacy of angiotensin-converting enzyme inhibitors and calcium channel blockers in hypertension

Article

Author: Cai, Shi-Kang ; Yao, You-Jian ; Gui, Mei

Background::

Currently, most studies primarily focus on directly comparing the efficacy and safety of angiotensin-converting enzyme inhibitors (ACEIs) and calcium channel blockers (CCBs), the two major classes of antihypertensive drugs. Moreover, the majority of studies are based on randomized controlled trials and traditional meta-analyses, with few exploring the efficacy and safety comparisons among various members of ACEIs and CCBs.

Methods::

ACEIs and CCB were searched for in randomized controlled trials in CNKI, Wanfang, VIP, China Biology Medicine Disc (Si-noMed), PubMed, EMbase, and Cochrane Library databases. The search can be conducted till November 2022. Stata software (version 16.0) and R 4.1.3 was used for statistical analysis and graphics plotting, applying mvmeta, gemtc, and its packages. Meta-regression analysis was used to explore the inconsistencies of the studies.

Results::

In 73 trials involving 33 different drugs, a total of 9176 hypertensive patients were included in the analysis, with 4623 in the intervention group and 4553 in the control group. The results of the analysis showed that, according to the SUCRA ranking, felodipine (MD = −12.34, 95% CI: −17.8 to −6.82) was the drug most likely to be the best intervention for systolic blood pressure, while nitrendipine (MD = −8.01, 95% CI: −11.71 to −4.18) was the drug most likely to be the best intervention for diastolic blood pressure. Regarding adverse drug reactions, nifedipine (OR = 0.32, 95% CI: 0.14–0.74) was the drug most likely to be the safest.

Conclusion::

The research findings indicate that nifedipine is the optimal intervention for reducing systolic blood pressure in hypertensive patients, nitrendipine is the optimal intervention for reducing diastolic blood pressure in hypertensive patients, and felodipine is the optimal intervention for safety.

100 Deals associated with Nitrendipine

External Link

KEGG	Wiki	ATC	Drug Bank
D00629	Nitrendipine	C08CA08	DB01054

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	CN	Jiangsu Aidea Pharmaceutical Co., Ltd.	01 Jan 1987

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2023	Not Applicable	Hypertension	59	Combined antihypertensive treatment with nitrendipine	mvayidrhdt(vqqorltcxt) = fcnjxzslah spvpbpqggd (kkjynodwzx )	-	27 Aug 2023
MOSES (Pubmed \| Stroke)	Phase 4	Stroke	1,405	Eprosartan	fkwdjnnnxn(xnzhwlalan) = qqysddbknl zrxzfkualt (kqhqmajfkr )	-	01 Jun 2005
MOSES (Pubmed \| Stroke)	Phase 4	Stroke	1,405	Nitrendipine	fkwdjnnnxn(xnzhwlalan) = lkvqemhjld zrxzfkualt (kqhqmajfkr )	-	01 Jun 2005

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