scholarly journals A randomized, double‐blind clinical trial to evaluate the efficacy and safety of a fixed‐dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension

2020 ◽  
Vol 22 (2) ◽  
pp. 261-269
Author(s):  
Woohyeun Kim ◽  
Kiyuk Chang ◽  
Eun Joo Cho ◽  
Jeong‐Cheon Ahn ◽  
Cheol Woong Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Dose Combination

scholarly journals Correction of vitamin D insufficiency with combined strontium ranelate and vitamin D3 in osteoporotic patients

2014 ◽  
Vol 170 (3) ◽  
pp. 441-450 ◽  
Author(s):  
R Rizzoli ◽  
B Dawson-Hughes ◽  
J-M Kaufman ◽  
P Fardellone ◽  
M L Brandi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Strontium Ranelate ◽  
Vitamin D Insufficiency ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Primary Osteoporosis ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Dose Combination

ObjectiveThis study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2 g/vitamin D31000 IU daily vs strontium ranelate 2 g daily for correcting vitamin D insufficiency in osteoporosis.DesignA 6-month international, randomized, double-blind, parallel-group, phase 3 study.MethodsA total of 518 men and postmenopausal women aged ≥50 years with primary osteoporosis (T-score ≤−2.5s.d.) and serum 25-hydroxyvitamin D (25(OH)D) >22.5 nmol/l were included. Patients were allocated to strontium ranelate 2 g/vitamin D31000 IU daily (n=413) or strontium ranelate 2 g daily (n=105). The participants received calcium 1 g daily. The primary endpoint was serum 25(OH)D at last post-baseline evaluation during 3 months.ResultsBoth groups were comparable at baseline. Mean baseline of 25(OH)D was 44.1±14.6 nmol/l. After 3 months, the percentage of patients with 25(OH)D ≥50 nmol/l was higher with strontium ranelate/vitamin D3vs strontium ranelate (84 vs 44%,P<0.001; adjusted between-group odds ratio=6.7; 95% CI, 4.2–10.9). The efficacy of the fixed-dose combination on 25(OH)D was maintained at 6 months (86 vs 40%,P<0.001). Mean 25(OH)D was 65.1 and 49.5 nmol/l, respectively, after 3 months and 66.9 and 45.4 nmol/l after 6 months. Physical performance improved in both groups. Falls were 17 and 20% in the strontium ranelate/vitamin D3and strontium ranelate groups respectively. Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinically relevant differences in safety were observed.ConclusionsThis study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D31000 IU for correction of vitamin D insufficiency in osteoporotic patients.

scholarly journals Fixed Dose Combination Therapy of Antioxidants in Treatment of Idiopathic Oligoasthenozoospermia: Results of a Randomized, Double-blind, Placebo-controlled Clinical Trial

2013 ◽  
Vol 4 (1) ◽  
pp. 6-13 ◽  
Author(s):  
Sonia Malik ◽  
Sanjay Kalra ◽  
PM Gopinath ◽  
Ajit Saxena ◽  
Bharti Kalra ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Combination Therapy ◽  
Sperm Motility ◽  
Sperm Count ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Dose Combination

ABSTRACT Introduction To assess the effectiveness and safety of fixed dose combination (FDC) of antioxidants in treatment of idiopathic oligoasthenozoospermia. Materials and methods Placebo-controlled, Double-blind, randomized, Parallel three arm, Multicentric trial. Setting Fertility clinics of five centers across India. Patients One hundred and thirty-eight male subjects, aged between 21 and 50 years and subfertile for 1 year or more with the following baseline sperm selection criteria: Concentration <15 million/ml and total sperm motility <40%. Intervention(s) Eligible subjects were randomized to either of the three arms in a double-blind manner, i.e. arm 1 was given 2 tablets twice daily of FDC of antioxidants (coenzyme-Q10: 50 mg, L-carnitine: 500 mg, lycopene: 2.5 mg and zinc: 12.5 mg); arm 2 was given 1 tablet of FDC of antioxidants and one tablet of placebo twice daily and arm 3 was two tablets twice daily of matching placebo all for 180 days. Main outcome measure(s) The primary outcome measures were improvement in sperm count and sperm motility, whereas pregnancy rate was the secondary efficacy outcome. Results Compared to placebo, a statistically significant improvement was seen in sperm count (14.8-26.35 in arm 1 and 14.37-24.8 million/ml in arm 2, p < 0.0001), and sperm total motility (39.2-51.6% in arm 1 and 38.4-50.1% in arm 2, p < 0.0001), at 90 days, and treatment further improved these parameters at day 180. No intergroup difference was seen between arm 1 and arm 2. Mild adverse event of upper gastrointestinal discomfort by 8 subjects (three in arm 1; one in arm 2 and four subjects in arm 3) were reported. No serious adverse event was seen in the study. Conclusion Exogenous administration of fixed dose combination of antioxidants is a safe and effective therapy in improving the male subfertility. How to cite this article Gopinath PM, Kalra B, Saxena A, Malik S, Kochhar K, Kalra S, Zaveri H. Fixed Dose Combination Therapy of Antioxidants in Treatment of Idiopathic Oligoasthenozoospermia: Results of a Randomized, Doubleblind, Placebo-controlled Clinical Trial. Int J Infertility Fetal Med 2013;4(1):6-13.

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