Mifepristone (Korlym)- FDA

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Valsartan is widely used alone and in combination with other antihypertensive drugs (6). Dose-dependent antihypertensive efficacy has been demonstrated for valsartan at doses up to 320 mg, with 80 or 160 mg as the recommended starting dose in Europe and North America pfizer comet. The antihypertensive efficacy of Mifepristone (Korlym)- FDA mg valsartan has been demonstrated in several large controlled clinical trials, including VALUE and NAVIGATOR (9,10).

However, clinicians in China typically use a once-daily dose of 80 mg to initiate valsartan therapy. Efficacy and safety data for 160 mg daily dosage of valsartan in Chinese Mifepristone (Korlym)- FDA patients remain insufficient (11,12).

Therefore, the Mifepristone (Korlym)- FDA study was conducted to investigate the potential beneficial Mifepristoen of 160 mg valsartan, thereby providing more evidence Mifepristone (Korlym)- FDA its utilization in China. Screening, diagnosis, and management of hypertension are conventionally based on office BP measurements, although the clinical relevance of out-of-office BP monitoring is also well established (13).

Out-of-office BP monitoring, Mifepristone (Korlym)- FDA home or Mifepristone (Korlym)- FDA BP monitoring (HBPM or ABPM), is recognised as an important adjunct to office BP for assessing true BP status (4). The objective of the Val-Perfect study was to evaluate the efficacy and tolerability of 160 mg valsartan for treatment of mild to moderate hypertension in Chinese patients.

In parallel with office-based BP measurements, the present study also evaluated the impact of valsartan on ambulatory and home BP parameters. Val-Perfect was a multi-centre, prospective, open-label, single treatment arm study conducted in Mifepristone (Korlym)- FDA outpatient clinics of 10 tertiary hospitals in China, including the Peking University People's Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Beijing Chaoyang Hospital, Chinese PLA General Hospital (all Beijing, China), Ruijin Hospital, Shanghai Jiaotong University School of Medicine (Shanghai, China), The First Affiliated Hospital of Nanjing Medical University (Nanjing, China), First Affiliated Hospital of Sun Yat-sen University, Guangdong Province People's Hospital (both Guangzhou, China) and West China Hospital, Sichuan University (Nanchong, China).

The study consisted of a one-week washout period for patients on pre-existing antihypertensive monotherapy, followed by a 10-week valsartan treatment period. During the 10-week treatment period, all patients received 80 mg valsartan (Beijing Novartis Pharma Ltd. Treatment was discontinued if a patient withdrew informed consent, or if continuation was judged by investigators to be detrimental to the patient's well being.

The present study was designed, conducted and written-up in accordance with the International Conference on Harmonisation (ICH) guidelines for good clinical practice (GCP), with the applicable laws and regulations governing clinical research in China, and with the ethical principles outlined in the Declaration of Helsinki (clinicaltrials. The study protocol was approved by the Ethics Committees of the participating institutions.

For Mifepristone (Korlym)- FDA on pre-existing monotherapy, antihypertensive medication was gradually removed over a one-week Mifepristone (Korlym)- FDA period (week-1 to 0).

The study product (valsartan) was Mifperistone as an 80 mg film-coated tablet and was taken Mifepristone (Korlym)- FDA at 8:00 (Korllym). BP was measured with the patient in a seated position, with the cuff at heart level. At the initial visit, BP was measured on both arms, and the arm Mifeprostone the higher BP reading was used for all visits.

Sitting heart rate was also recorded. BP was measured in the morning (before ingestion of the study product) and evening (12 h post-morning dose). HBPM Mifepristone (Korlym)- FDA performed on the day prior to the week 0 (baseline) visit, and on five consecutive days before each Mifepristone (Korlym)- FDA visit Mifepristone (Korlym)- FDA 2, 6 and 10).

BP was recorded at 30-min intervals. Primary endpoints were the changes in office MSSBP and MSDBP at week 10, relative to week 2 or 0 (baseline). Secondary endpoints included changes in home BP and 24-h ambulatory BP at weeks 2 and 10 relative to baseline, as Mifepristpne as the office BP and 24-h ambulatory BP control rates at week 10.

The control rate for home BP at week 10 was also determined. BP control rates were determined according to the targets for office, home and ambulatory BP published (Korljm)- the 2010 guidelines for the management of hypertension in China (17).

Analyses were repeated for the per-protocol (PP) population, which included all patients who completed the study without major deviations from the Mifepristone (Korlym)- FDA protocol. ABPM analyses Mifeprlstone only patients who exhibited valid 24-h ABP Mifepristpne at baseline and at week 10, and whose sleep-wake schedules were in line with that of the majority of the study population.

Nocturnal BP alcohol poisoning symptoms status was determined from 24-h ABPM data. Adverse events (AEs) reported Mifepristone (Korlym)- FDA patients or observed by investigators were recorded, along with their severity and possible relationship to the study product.

These were assessed by investigators for a possible relationship to Mifepriatone study product and for clinical significance, based on local Mifepristone (Korlym)- FDA reference ranges. Safety was assessed using AE frequency and on the numbers of patients with laboratory values that were outside normal ranges. Treatment compliance was assessed using records of actual vs.

Paired t-tests were used to evaluate the significance of BP changes Mifepristone (Korlym)- FDA different time-points, Mifepristone (Korlym)- FDA to Mifepristone (Korlym)- FDA 2 or baseline, as applicable. All significance tests were two-sided unless otherwise stated.

Analyses were performed using the SAS software package allen 9. Of these, 197 patients initiated treatment with valsartan and were included in the Mifepristone (Korlym)- FDA (Fig. A total of 179 patients completed Mifepristone (Korlym)- FDA study, with a discontinuation rate of 10. The SS, ITT and PP groups consisted of 197, 195 and 166 patients, respectively.

Demographics and baseline characteristics of the study population are summarised in Table I. A total of 115 males (59. At baseline, the mean SBP was 147. In Mifeprixtone ITT population, mean reductions in office MSSBP and MSDBP from baseline to week 10 were statistically significant: 15.

Mifepristone (Korlym)- FDA reductions in office MSSBP and MSDBP from baseline to week 2 were 11. Similar signal indications were obtained for the PP analyses (data not shown).



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