NEWS HIGHLIGHTS
Published Studies Related to Nifediac (Nifedipine)
Two dose regimens of nifedipine for management of preterm labor: a randomized controlled trial. [2009.09]
We compared two dose regimens of tocolytic oral nifedipine. Women with singleton pregnancies admitted in preterm labor (24 to 34 weeks) were randomized to high-dose (HD) nifedipine ( N = 49; 20 mg loading dose, repeated in 30 minutes, daily 120 to 160 mg slow-release nifedipine for 48 hours followed by 80 to 120 mg daily until 36 weeks) or low-dose (LD) nifedipine ( N = 53; 10 mg, up to four doses every 15 minutes, daily 60 to 80 mg slow-release nifedipine for 48 hours followed by 60 mg daily until 36 weeks)...
A randomized placebo-controlled study on the effect of nifedipine on coronary endothelial function and plaque formation in patients with coronary artery disease: the ENCORE II study. [2009.07]
CONCLUSION: The ENCORE II trial demonstrates in a multi-centre setting that calcium channel blockade with nifedipine for up to 2 years improves coronary endothelial function on top of statin treatment, but did not show an effect of nifedipine on plaque volume.
Effects of enalapril or nifedipine on muscle strength or functional capacity in elderly subjects. A double blind trial. [2009.06]
INTRODUCTION: The inhibition of angiotensin-converting enzyme could be useful to avoid sarcopenia in the elderly... CONCLUSION: In this group of elderly subjects, enalapril was not superior to nifedipine with regard to the age-related decline of muscle performance.
The effects of the tocolytics atosiban and nifedipine on fetal movements, heart rate and blood flow. [2009.06]
CONCLUSION: This study demonstrates for the first time the direct effects of atosiban on fetal movement, heart rate and blood flow. Tocolysis with either atosiban or nifedipine combined with betamethasone administration appears to have no direct fetal adverse effects.
To compare the efficacy and safety of nifedipine sustained release with Ginkgo biloba extract to treat patients with primary Raynaud's phenomenon in South Korea; Korean Raynaud study (KOARA study). [2009.05]
This study examined the efficacy and safety of nifedipine sustained release (nifedipine SR) compared with Ginkgo biloba extract as treatment for primary Raynaud's phenomenon (RP) in Korea. Primary RP were screened and assigned to either the nifedipine SR group (Group N) or the Ginkgo biloba extract group (Group G) in the ratio of 2:1...
Clinical Trials Related to Nifediac (Nifedipine)
Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension [Completed]
This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in
blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either
Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then
switched back to the original drug for one day. Blood samples, blood pressure, and heart
rate are taken before and after each treatment period.
Losartan Therapy in Pulmonary Hypertension [Completed]
In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs)
and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the
inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration
of endothelial dysfunction. These beneficial effects, render those agents appropriate for use
in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs
in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was
compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary
hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise
test, and endothelin-1 levels. Losartan is as effective as nifedipine for reducing Doppler
echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However
the short-term use of losartan or nifedipine had no statistically significant effect on
endothelin-1 levels in patients with PHT.
Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery [Not yet recruiting]
To evaluate the treatment efficacy and safety usig extended release nifedipine, as
maintenance therapy to pregnant women who were hospitalized and treated for preterm labor
until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the
treatment group and the control (no treatment) group.
The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome
will be the side effects of the medication and the newborn/mother health variables.
An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects [Not yet recruiting]
This is an open label study. The study will consist of 1 treatment group: coated Nifedipine
suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal
fissure.
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension [Not yet recruiting]
This will be a multi-center, prospective, randomized, open-label, parallel design, two arm
comparator trial.
In the proposed study, the investigators will compare low-dose combination therapy of
Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect
to their blood pressure-decreasing effects in patients with essential hypertension.
The study consists of a screening visit, followed by randomization and administration of
either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg
for 12 weeks of treatment.
The primary efficacy parameters will be mean systolic blood pressure (SBP) and diastolic
blood pressure (DBP) on office BP monitoring at 12 weeks of treatment compared to baseline.
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