Sustained antihypertensive activity of diltiazem SR: double-blind, placebo-controlled study with 24-hour ambulatory blood pressure monitoring.

Abstract:

:A new polymeric matrix technology provides a sustained-release formulation of diltiazem hydrochloride (diltiazem SR) suitable for once-daily therapy. The efficacy and safety of diltiazem SR were evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. After a single-blind, placebo lead-in period, 275 patients with mild to moderate essential hypertension were assigned to receive placebo or diltiazem SR 120, 240, 360, or 480 mg once daily for 4 weeks. The efficacy evaluation was based on office and 24-hour ambulatory blood pressure monitoring. Twenty-four hours after the last dose in the 4-week, double-blind treatment period, the mean reduction from baseline in supine diastolic blood pressure ranged from 5.1 to 10.6 mm Hg in the diltiazem SR 120- to 480-mg groups, resulting in a significant linear trend across all treatments (P less than .001). Reductions in systolic blood pressure were similar. Ambulatory blood pressure monitoring, performed in 138 patients, confirmed the dose-response relationship and showed consistent antihypertensive activity throughout the 24-hour dosing interval. The percentage of patients reporting adverse events was similar in the placebo- and active-treated groups. The results of this study indicate that diltiazem SR is well tolerated, lowers blood pressure in a dose-related manner, and provides sustained activity throughout the 24-hour dosing interval.

journal_name

J Clin Pharmacol

authors

Whelton A,Eff J,Magner DJ

doi

10.1002/j.1552-4604.1992.tb03887.x

subject

Has Abstract

pub_date

1992-09-01 00:00:00

pages

808-15

issue

9

eissn

0091-2700

issn

1552-4604

journal_volume

32

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
  • Pharmacokinetics, pharmacodynamics, and safety of microencapsulated octreotide acetate in healthy subjects.

    abstract::The pharmacokinetics, pharmacodynamics, and safety of the marketed formulation of microencapsulated octreotide acetate were evaluated in an open-label study in 22 healthy cholecystectomized subjects. Each subject received a single 30 mg dose of microencapsulated octreotide acetate intramuscularly (i.m.). Concentration...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1177/00912700022009242

    authors: Chen T,Miller TF,Prasad P,Lee J,Krauss J,Miscik K,Kalafsky G,McLeod JF

    更新日期:2000-05-01 00:00:00

  • A pharmacodynamic and pharmacokinetic comparison of intravenous quinaprilat and oral quinapril.

    abstract::Quinaprilat is the active metabolite of quinapril, an orally active angiotensin-converting enzyme (ACE) inhibitor. The dose-response and duration-of-effect after single intravenous doses of quinaprilat and placebo (part A) and after administration of oral quinapril solution and intravenous quinaprilat (part B) were as...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/j.1552-4604.1996.tb05028.x

    authors: Breslin E,Posvar E,Neub M,Trenk D,Jahnchen E

    更新日期:1996-05-01 00:00:00

  • A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment.

    abstract::The pharmacokinetics and safety of a single oral dose of 200-mg plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD) in oral solution (Epidiolex in the United States; 100 mg/mL) were assessed in subjects with mild to severe hepatic impairment (n =  8 each for mild and moderate, n = 6 for sever...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1002/jcph.1412

    authors: Taylor L,Crockett J,Tayo B,Morrison G

    更新日期:2019-08-01 00:00:00

  • Effect of cyclosporine on the pharmacokinetics of aliskiren in healthy subjects.

    abstract::To explore the clinical relevance of inhibition of multidrug resistance transporter 1 and organic anion transporting polypeptide transporter, a drug-drug interaction study was conducted using aliskiren and cyclosporine. This was an open-label, single-sequence, parallel-group, single-dose study in healthy subjects. Sub...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1177/0091270010385934

    authors: Rebello S,Compain S,Feng A,Hariry S,Dieterich HA,Jarugula V

    更新日期:2011-11-01 00:00:00

  • Phase 1 First-in-Human, Single- and Multiple-Ascending Dose, and Food Effect Studies to Assess the Safety, Tolerability, and Pharmacokinetics of Presatovir for the Treatment of Respiratory Syncytial Virus Infection.

    abstract::Respiratory syncytial virus (RSV)-associated respiratory tract infection is a leading cause of hospitalizations in infants for which no effective treatment exists. RSV infection is also an important cause of respiratory disease in adults and immunocompromised patients. Presatovir (GS-5806) is an orally bioavailable an...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1112

    authors: German P,Xin Y,Chien JW,Weng W,Mackman R,Lewis SA,Meng A,Ling J,Mathias A

    更新日期:2018-08-01 00:00:00

  • Lack of electrocardiographic effect of dexlansoprazole MR, a novel modified-release formulation of the proton pump inhibitor dexlansoprazole, in healthy participants.

    abstract::The effect of the proton pump inhibitor dexlansoprazole, an enantiomer of lansoprazole, on QT intervals was assessed after oral administration of a modified-release formulation of dexlansoprazole (dexlansoprazole MR). In this randomized, positive-comparator, placebo-controlled, 4-period crossover study, 40 healthy par...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1177/0091270009339188

    authors: Vakily M,Wu J,Atkinson SN

    更新日期:2009-12-01 00:00:00

  • Small animal model of weightlessness for pharmacokinetic evaluation.

    abstract::As the United States seeks a greater presence in space, physiologic changes associated with space flight become of greater concern. Exposure to a weightless environment has been shown to have numerous effects on body composition and organ function. Alterations include decreases in muscle and liver mass, changes in bon...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1002/j.1552-4604.1994.tb02023.x

    authors: Feldman S,Brunner LJ

    更新日期:1994-06-01 00:00:00

  • Pharmacokinetics of capacity-limited systems.

    abstract::Nonlinearities are commonplace in pharmacokinetics and most frequently occur because of a limited concentration of biological material available for interaction with relatively high concentrations of drugs. The Michaelis-Menten-type function can be applied to metabolism, transport, and binding phenomena that display c...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1002/j.1552-4604.1989.tb03369.x

    authors: Jusko WJ

    更新日期:1989-06-01 00:00:00

  • Nizatidine suppression of basal gastric acid output: a comparison of two intravenous dosage regimens.

    abstract::To study the pharmacokinetics and pharmacodynamics of two intravenous nizatidine dosing regimens, serial plasma concentrations and continuous intragastric pH were monitored simultaneously in 10 subjects with a documented history of duodenal or gastric ulcers. A 24-hour gastric pH profile was characterized for a 300 mg...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/j.1552-4604.1989.tb03259.x

    authors: Danziger L,Furmaga KM,Rodvold KA,Bombeck CT,Fischer JH

    更新日期:1989-10-01 00:00:00

  • Investigation of safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of a long-acting α-MSH analog in healthy overweight and obese subjects.

    abstract::MC4-NN2-0453 is a novel, long-acting, selective, melanocortin-4-receptor agonist developed for treatment of obesity. This first-human-dose, randomized, double-blind, placebo-controlled trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MC4-NN2-0453 in ov...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/jcph.211

    authors: Royalty JE,Konradsen G,Eskerod O,Wulff BS,Hansen BS

    更新日期:2014-04-01 00:00:00

  • Bumetanide: a new diuretic. Results of clinical efficacy and safety in patients with congestive heart failure.

    abstract::A clinical study of bumetanide, a new diuretic, was conducted in outpatients of a cardiology clinic to determine its long-term effectiveness and safety in the treatment of peripheral edema due to congestive heart failure. The drug was administered for at least 24 weeks on a selected group of 34 patients. The patients ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1981.tb05685.x

    authors: Handler B,Dhingra RC,Rosen KM

    更新日期:1981-11-01 00:00:00

  • Clinical effects of pentazocine in hospitalized medical patients.

    abstract::Of 17,068 hospitalized medical patients monitored in a drug surveillance program, 616 (3.6 per cent) received pentazocine hydrochloride orally and 816 (4.8 per cent) received pentazocine lactate parenterally during one or more admissions. Unsatisfactory analgesic efficacy as judged by each patient's physician was near...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1975.tb02357.x

    authors: Miller RR

    更新日期:1975-02-01 00:00:00

  • Studies on the pharmacokinetics and pharmacodynamics of the beta-adrenergic blocking agent sotalol in normal man.

    abstract::After intravenous injection, sotalol follows a two-compartment distribution pattern. The processes of distribution and elimination are of first order; the intravenous biological half-life is 6 to 8 hours. The drug is mainly excreted by glomerular filtration via the kidney, and metabolites are not found. Of the pharmac...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1979.tb02517.x

    authors: Schnelle K,Klein G,Schinz A

    更新日期:1979-08-01 00:00:00

  • Intravitreal Injection of a Rho-Kinase Inhibitor (Fasudil) for Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy.

    abstract::This study evaluated the effects of intravitreal injection of fasudil (IVF), a Rho-kinase inhibitor, in cases of recent-onset nonarteritic anterior ischemic optic neuropathy (NAION). In this interventional case series, 13 eyes of 13 patients diagnosed with NAION within 14 days of onset were included. The affected eyes...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.655

    authors: Sanjari N,Pakravan M,Nourinia R,Esfandiari H,Hafezi-Moghadam A,Zandi S,Nakao S,Shah-Heidari MH,Jamali A,Yaseri M,Ahmadieh H

    更新日期:2016-06-01 00:00:00

  • Evaluation of the effects of the weak CYP3A inhibitors atorvastatin and ethinyl estradiol/norgestimate on lomitapide pharmacokinetics in healthy subjects.

    abstract::Lomitapide is a microsomal triglyceride transfer protein inhibitor approved as an adjunctive treatment for adult patients with homozygous familial hypercholesterolemia. Lomitapide is extensively metabolized via cytochrome P450 3A (CYP3A) and is a weak CYP3A inhibitor. Two phase 1 open-label, randomized (1:1), 2-arm dr...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/jcph.581

    authors: Patel G,King A,Dutta S,Korb S,Wade JR,Foulds P,Sumeray M

    更新日期:2016-01-01 00:00:00

  • Improving the diagnosis of hypersensitivity reactions associated with sulfonamides.

    abstract::The differential diagnosis of idiosyncratic adverse drug reactions (ADRs) is difficult because symptoms are seldom pathognomonic. The authors compared the performance of two new diagnostic aids in the differential diagnosis of 27 cases of skin reactions associated with sulfonamide therapy. One test, the Bayesian Adver...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1994.tb04736.x

    authors: Lanctôt KL,Ghajar BM,Shear NH,Naranjo CA

    更新日期:1994-12-01 00:00:00

  • A model for estimating individualized valproate clearance values in children.

    abstract::To evaluate the population pharmacokinetics of valproic acid in children, 97 steady-state serum valproate concentration measurements were gathered during normal, routine, outpatient care of 52 children with epilepsy (1.2-16 years of age). Levels were obtained from patients receiving valproate monotherapy (49%) or valp...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1995.tb04020.x

    authors: Botha JH,Gray AL,Miller R

    更新日期:1995-10-01 00:00:00

  • Computer-assisted molecular modeling: indispensable tools for molecular pharmacology.

    abstract::Ball-and-stick mechanical models, typically associated with chemists, have been helpful in understanding structural problems and the relationship between structure and biologic activity. With progress in computer speed, graphics performance, and software innovation, molecules of biological interest can be subjected to...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1002/j.1552-4604.1993.tb03915.x

    authors: Bowen JP,Charifson PS,Fox PC,Kontoyianni M,Miller AB,Schnur D,Stewart EL,Van Dyke C

    更新日期:1993-12-01 00:00:00

  • Physiologically Based Pharmacokinetic Approach Can Successfully Predict Pharmacokinetics of Citalopram in Different Patient Populations.

    abstract::A physiologically based pharmacokinetic model (PBPK) was built for citalopram using Simcyp-based absorption, distribution, metabolism, and excretion simulator. Various physicochemical properties of citalopram were obtained from the published literature. The in vitro-in vivo extrapolation method was used to predict cle...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1541

    authors: Wu X,Zhang H,Miah MK,Caritis SN,Venkataramanan R

    更新日期:2020-04-01 00:00:00

  • Peripheral hemodynamic and humoral effects of oral zofenopril calcium (SQ. 26,991) in patients with congestive heart failure.

    abstract::In 14 patients with congestive heart failure (CHF) of various grade (NYHA class 2-4) the effects of zofenopril calcium (SQ 26,991) on blood pressure and forearm circulation were studied by venous occlusion plethysmography. Changes in plasma renin activity (PRA), aldosterone, Atrial natriuretic factor (ANF) and arginin...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1989.tb03282.x

    authors: Borghi C,Magelli C,Boschi S,Costa FV,Capelli M,Varani E,Magnani B,Ambrosioni E

    更新日期:1989-12-01 00:00:00

  • Risk factors not addressed in antihypertensive therapy based solely on blood pressure control.

    abstract::There has been a considerable revolution in the field of hypertension therapy. We have gone through an era in which patients with severe hypertension and those with accelerated hypertension had a very short life expectancy. Currently blood pressure can be readily controlled with a marked improvement in longevity. We h...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1002/j.1552-4604.1993.tb03957.x

    authors: Somberg J,Ehrenpreis S,Shroff G,Khosla S

    更新日期:1993-03-01 00:00:00

  • Impulsive-aggressive traits, serotonin function, and alcohol-enhanced aggression.

    abstract::Although alcohol consumption is involved in most acts of violence, most people do not become violent when they drink. Individuals also respond differently to alcohol on laboratory measures of aggression. The objective of this study was to determine whether individual differences in the effects of alcohol on a laborato...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1177/0091270004270457

    authors: Fulwiler C,Eckstine J,Kalsy S

    更新日期:2005-01-01 00:00:00

  • Feasibility of a breath test for monitoring adherence to vaginal administration of antiretroviral microbicide gels.

    abstract::Adherence to microbicide gel use is critical to optimizing effectiveness in preventing human immunodeficiency virus transmission. The authors hypothesized that ester taggants added to vaginal gels would generate exhaled alcohol and ketone metabolites and provide a "breath test" for vaginal gel use. This 2-arm (vaginal...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1177/0091270011434157

    authors: Morey TE,Wasdo S,Wishin J,Quinn B,van der Straten A,Booth M,Gonzalez D,Derendorf H,Melker RJ,Dennis DM

    更新日期:2013-01-01 00:00:00

  • Clinical and bacteriological evaluation of amikacin in severe gram-negative infections.

    abstract::Amikacin was administered to 51 patients with serious Gram-negative infections. A favorable clinical outcome was observed in 32 patients (62 per cent). No major untoward effects were noted. The severity of the underlying disease and the site of the infection were important for the outcome. Urinary tract infections res...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1002/j.1552-4604.1976.tb01520.x

    authors: Klastersky J,Van Beerse D,Schoutens E,De Temmerman P,Yourassowsky E

    更新日期:1976-04-01 00:00:00

  • Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.

    abstract::In June 1999, the Food and Drug Administration issued draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action. The purpose of this opinion paper is to highlight the need for a balanced scientific debate before this guidance is used by underscoring the areas in the document that a...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1177/00912700022009440

    authors: Harrison LI

    更新日期:2000-07-01 00:00:00

  • A Drug-Drug Interaction Study to Evaluate the Effect of TAS-303 on CYP3A Activity in the Small Intestine and Liver.

    abstract::TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d7 ] acetate hydrochloride) is a novel selective noradrenaline reuptake inhibitor being developed for the treatment of stress urinary incontinence. An in vitro study and a physiologically based pharmacokinetic model simulation showed that TAS-303 had inhibit...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1583

    authors: Kumagai Y,Fujita T,Maeda M,Sasaki Y,Nagaoka M,Huang J,Takenaka T,Kawai M

    更新日期:2020-06-01 00:00:00

  • Feasibility of microdialysis for determination of protein binding and target site pharmacokinetics of colistin in vivo.

    abstract::Tissue pharmacokinetics and plasma protein binding of colistin have not been described in humans in vivo. Colistin concentrations in plasma, muscle, and subcutis of healthy volunteers were measured by microdialysis after a single dose of 2.5 million IU of colistin methanesulfonate. In vitro microdialysis experiments a...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1002/jcph.419

    authors: Matzneller P,Gobin P,Lackner E,Zeitlinger M

    更新日期:2015-04-01 00:00:00

  • Biological activity of cannabichromene, its homologs and isomers.

    abstract::Cannabichromene (CBC) is one of four major cannabinoids in Cannabis sativa L. and is the second most abundant cannabinoid in drug-type cannabis. Cannabichromene and some of its homologs, analogs, and isomers were evaluated for antiinflammatory, antibacterial, and antifungal activity. Antiinflammatory activity was eval...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1981.tb02606.x

    authors: Turner CE,Elsohly MA

    更新日期:1981-08-01 00:00:00

  • Pharmacokinetic and pharmacodynamic profiles of vapiprost, a selective, long-lasting thromboxane receptor antagonist, after single and multiple oral administration to healthy volunteers.

    abstract::A selective thromboxane A2 (TXA2) receptor blocking agent, vapiprost, was orally administered to healthy male Japanese volunteers to investigate the pharmacokinetic and pharmacodynamic properties. The time-profile of vapiprost concentration in plasma was determined and the effects of the drug on platelet aggregation i...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/j.1552-4604.1991.tb01917.x

    authors: Uematsu T,Nagashima S,Mizuno A,Hirano K,Nakashima M

    更新日期:1991-09-01 00:00:00

  • Effect of Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of the Iminosugar Sinbaglustat.

    abstract::Sinbaglustat (ACT-519276), a brain-penetrating inhibitor of glucosylceramide synthase and nonlysosomal glucosylceramidase, is developed as a new therapy for lysosomal storage disorders. In the first-in-human study, sinbaglustat was primarily excreted unchanged in urine. This study was conducted to evaluate the effect ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1808

    authors: Melchior M,Dingemanse J,Alatrach A,Feldkamp T,Sidharta PN,Géhin M

    更新日期:2020-12-23 00:00:00