Decitabine night shift workers and pregnant or nursing women or women of childbearing age not using a medically approved means of contraception. Patients with a contraindication to a placebo run-in peri patients treated with any investigational drug therapy within month of signing the informed conse those who had previously experienced symptoms characteristic of angioedema during treat-ment with angiotensin-converting enzyme in-hibitors or AR those with a history of drug or alcohol dependency within months before signing the informed consent fo and those with known hypersensitivity to anyponent of the study drugs were excluded from the study. Patients with a his-tory of nopliance or inability toply with prescribed medications or protocol procedures and any other clinical condition th in the opinion of the investigat would not allow safepletion of the protocol and safe administration of telmisartan and amlodipine were not permitted to E7080 enter the measuring equipment and recorded to the nearest mm Hg.
BP measurements were performed on the same arm and preferably by the same person at all study visits. After a -minute rest in the seated positi BP measurements were taken minutes apart. Patients then had their BP taken within minute of quiet stand-ing. Only standing BP measurement was taken. ABPM equipment was provided by Medifacts Inter-national Inc Starting in the morning at A 4-hour BP measurements were taken at baseline and at day 7 using the vali-dated and calibrated SpaceLabs Model monitor . Measures trilostane 13647-35-3 were taken every 0 minutes throughout the day and night and analyzed using Web-Heart ABPM software . The primary end point was the change from baseline in mean seated trough cuff SBP after weeks of treat-ment. The key secondary ef acy end point was a change from baseline in mean seated trough cuff SBP after and weeks of treatment. Additional secondary end points included a change from baseline in mean seated trough cuff diastolic BP after and weeks of treatment as well as SBP and BP goal attainmen response rates A protocol amendme approved on September 5 and a change from baseline in the urine albumin: creatinine rati measured in spot urine) after weeks of treatment.
For the ABPM substu the secondary end points included a change from baseline in the buy nebivolol 4-hour ABPM mean for SBP after weeks of treat-ment; changes from baseline in DBP and SBP hourly means over the 4-hour dosing interval as measured by ABPM after weeks of treatment; and proportion of patients achieving 4-hour study targets of mean Medication Restrictions SBP/DBP 3 mm Hg and 2 mm Hg as Coitant administration of any medication known to affect BP was not permitted during the trial.
March assessed by ABPM after weeks of treatment. Pre-specid subgroup analyses of SBP by s a ra Clinical Therapeutics body mass inde and baseline SBP category were conducted. Safety Proe and Tolerability All adverse events that occurred after the patient signed the informed consent were recorded. Any ad-verse events that were present at the time that the pa-tient discontinued participation in the trial were fol-lowed until the event was physiology resolved or for a period of time agreed on by the investigator and the Boehringer Ingelheim clinical monitor. Pulse rate was measured as beats per minute in the clinic.
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