Dynacirc CR (Isradipine) - Summary

DYNACIRC CR SUMMARY

DynaCirc CR^®(isradipine)Controlled Release Tablets

DynaCirc CR® contains isradipine, a calcium antagonist. It is available for once-daily oral administration as a controlled release 5 mg and 10 mg tablet for DynaCirc CR® (isradipine). DynaCirc CR® is a registered trademark for isradipine GITS (Gastrointestinal Therapeutic System) tablets.

DynaCirc CR® (isradipine) is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.

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NEWS HIGHLIGHTS

Published Studies Related to Dynacirc CR (Isradipine)

Phase II safety, tolerability, and dose selection study of isradipine as a potential disease-modifying intervention in early Parkinson's disease (STEADY-PD). [2013]
Isradipine, a dihydropyridine calcium channel antagonist, has been shown to be neuroprotective in animal models of Parkinson's disease (PD). To establish a dosage of isradipine controlled-release (CR) that is tolerable and demonstrates preliminary efficacy for use in a future pivotal efficacy trial a Phase 2, randomized, double-blind, parallel group trial (Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease [STEADY-PD]) was undertaken in subjects with early PD not requiring dopaminergic therapy (dopamine agonists or levodopa) randomized 1:1:1:1 to 5, 10, or 20 mg of isradipine CR or matching placebo daily...

Effects of isradipine on cocaine-induced changes in cognitive performance in recently abstinent cocaine-dependent individuals. [2005.12]
Recently abstinent cocaine-dependent individuals, compared with healthy controls, appear more likely to exhibit deficits in cognitive performance and attention. Individuals with such cognitive deficits might be less able to avail themselves of rehabilitative or relapse-prevention efforts.

Effects of isradipine, a dihydropyridine-class calcium-channel antagonist, on d-methamphetamine's subjective and reinforcing effects. [2005.06]
In healthy human volunteers, we have previously shown that isradipine, a dihydropyridine-class calcium-channel antagonist, reduces some methamphetamine-induced positive subjective effects associated with its abuse liability, presumably by antagonizing cortico-mesolimbic dopamine pathways... Depending upon conditioning status, isradipine can reduce some methamphetamine-induced positive subjective and reinforcing effects associated with its abuse liability in methamphetamine addicts.

Effects of isradipine on methamphetamine-induced changes in attentional and perceptual-motor skills of cognition. [2005.03]
CONCLUSION: Our results do not support the further testing of isradipine as a medication for improving the cognitive impairments that have been associated with chronic methamphetamine use.

Kinetic and cardiovascular comparison of immediate-release isradipine and sustained-release isradipine among non-treatment-seeking, cocaine-dependent individuals. [2005.01]
The authors sought to determine whether sustained-release (SR) isradipine provided comparable systemic availability to that of immediate-release (IR) isradipine in non-treatment-seeking, cocaine-dependent individuals.The more favorable cardiovascular profile of SR isradipine would, however, make it more appropriate as an investigational medication for the treatment of stimulant dependence and related neurovascular disorders.

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Clinical Trials Related to Dynacirc CR (Isradipine)

Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease [Completed]

Parkinson's Disease Isradipine Safety Study [Completed]
The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is being completed now and is conducted in preparation to NIH submission of the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is conducted in parallel with Dr. Surmeier's work on further development of the preclinical data. The focus of his work now is to establishing the correlation between the dose that demonstrated neuroprotective effect in animal model and the dose used for clinical practice. Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended dose range. We expect 10% attrition due to hypotensive effect of the agent. Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based on the blood pressure reading.

Adjunctive Isradipine for the Treatment of Bipolar Depression [Recruiting]
This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an "add-on" to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.

Improving Buprenorphine Detoxification Outcomes With Isradipine [Recruiting]
This application seeks to address the problem of opioid withdrawal by examining the utility of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification. This project will address the need for improved detoxification strategies by assessing the tolerability and preliminary efficacy of adjunct isradipine during a BUP detoxification in opioid-dependent participants. This pilot clinical trial will determine the potential utility of the L-type CCB isradipine to improve treatment outcomes in up to 60 opioid-dependent individuals undergoing a BUP detoxification procedure. Specifically, this study will determine the efficacy of isradipine to reduce withdrawal symptoms, craving, and illicit use of opioids in opioid-dependent individuals undergoing BUP detoxification and determine the tolerability and safety of controlled-release isradipine (10 mg/day) in opioid-dependent individuals undergoing BUP detoxification. Currently, the only FDA-approved medications for opioid withdrawal are the opioid agonists methadone and BUP, both of which have abuse liability. Our findings, if positive, will support a larger phase II clinical trial.

Efficacy of Isradipine in Early Parkinson Disease [Recruiting]
The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.

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Reports of Suspected Dynacirc CR (Isradipine) Side Effects

Blood Pressure Inadequately Controlled (3),  Blood Pressure Increased (3),  Product Quality Issue (3),  Medication Residue (2),  Diabetes Mellitus Inadequate Control (2),  Weight Increased (1),  Oedema Peripheral (1),  Dizziness (1),  Drug Effect Decreased (1),  Musculoskeletal Pain (1), more >>