Adalat CC (Nifedipine) - Summary

ADALAT CC SUMMARY

Adalat^® CC is an extended release tablet dosage form of the calcium channel blocker nifedipine.

Adalat CC is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

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NEWS HIGHLIGHTS

Published Studies Related to Adalat CC (Nifedipine)

Vitamin D and nifedipine in the treatment of Chinese patients with grades I-II essential hypertension: a randomized placebo-controlled trial. [2014]
the treatment of patients with essential hypertension... CONCLUSIONS: Vitamin D supplementation can reduce blood pressure in patients with

Oral nifedipine or intravenous labetalol for hypertensive emergency in pregnancy: a randomized controlled trial. [2013]
hypertensive emergency of pregnancy... CONCLUSION: As administered in this trial, oral nifedipine lowered blood pressure

Effect of nifedipine on choroidal blood flow regulation during isometric exercise. [2012]
healthy subjects... CONCLUSIONS: In conclusion, the data of the present study suggest that nifedipine

Comparison of the efficacy of nifedipine and hydralazine in hypertensive crisis in pregnancy. [2011.11]
Intravenous hydralazine is a commonly administered arteriolar vasodilator that is effective for hypertensive emergencies associated with pregnancy...

Adjuvant Tamsulosin or Nifedipine After Extracorporeal Shock Wave Lithotripsy for Renal Stones: A Double Blind, Randomized, Placebo-controlled Trial. [2011.11]
OBJECTIVE: To evaluate the effects of the adjuvant use of tamsulosin or nifedipine after extracorporeal shock wave lithotripsy for nonlower pole kidney stones 5-20 mm in size... CONCLUSION: The stone-free rates after extracorporeal shock wave lithotripsy with adjuvant tamsulosin or nifedipine were significantly increased only for nonlower pole renal stones 10-20 mm in size compared with placebo. Nifedipine was associated with more adverse effects than placebo. Copyright A(c) 2011 Elsevier Inc. All rights reserved.

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Clinical Trials Related to Adalat CC (Nifedipine)

Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions [Completed]
The present study will be performed to investigate and to compare the in-vivo performance of the two investigational products Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic parameters after oral single dose administrations in the fasted and fed state.

Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers [Completed]
Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female volunteers.

Nifedipine Pharmacokinetics and Pharmacodynamics When Used as a Tocolytic in Acute Threatened Preterm Labour [Recruiting]
Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO, 15 million children are born prematurely (gestational age < 37 weeks) in the world each year while 7% of them die because of complications associated with prematurity. Despite constant improvement of obstetrical care, the number of preterm births has increased over the last decades and prematurity is still the most frequent cause of prenatal hospitalization in industrialized countries. The American College of Obstetricians and Gynecologists as well as the Royal College of Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of acute threatened preterm labour. Clinical experience show however an important variability in treatment response among pregnant women. In spite of its large use in obstetrics as a tocolytic agent, nifedipine is prescribed off-label. As a consequence no international consensus on optimal dose schedule has so far been proposed. Small sample size and heterogeneousness of tocolysis administration protocols make it difficult to compare the little data available on the pharmacokinetics of nifedipine in pregnant women. Nevertheless an important interindividual variability in concentrations has been identified (CV=12-76%) but very few studies have investigated the possible reasons of this variability in pregnant women. Genetic and environmental factors involved in drug distribution and metabolism (e. g. enzymatic activity, CYP 3A5 genotype) might partially explain variability in drug levels and therefore differences in treatment response. The goal of this study is to quantify the variability in nifedipine pharmacokinetics and identify potential genetic and non-genetic sources of variability in nifedipine pharmacokinetics in pregnant women. The relationship between concentration and treatment response will be evaluated and will serve to propose optimal dosage regimen to improve efficacy and reduce side effects associated with this treatment.

Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study [Completed]
This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).

Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed [Completed]
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.

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Reports of Suspected Adalat CC (Nifedipine) Side Effects

Pain (4),  Pyrexia (4),  White Blood Cell Count Decreased (4),  Fluid Retention (3),  Altered State of Consciousness (3),  Drug Ineffective (2),  Hypoglycaemia (2),  Cardiac Disorder (2),  Feeling Hot (2),  Malabsorption (2), more >>