Atenolol vs. Amiloride-Hydrochlorothiazide in the Treatment of Mild to Moderate Hypertension: A Double-Blind, Crossover, Placebo-Controlled Study

1987 ◽  
Vol 21 (1) ◽  
pp. 43-46 ◽  
Author(s):  
Michael Lischner ◽  
Ruth Lang ◽  
Itzhak Jutrin ◽  
Mordchai Ravid
Keyword(s):  
Moderate Hypertension ◽  
Antihypertensive Effect ◽  
Blocking Agent ◽  
Associate Professor ◽  
Senior Resident ◽  
Controlled Study ◽  
Double Blind ◽  
Once Daily ◽  
Tel Aviv ◽  
School Of Medicine

The antihypertensive effect of atenolol 100 mg was compared to that of amiloride HCl 5 mg + hydrochlorothiazide 50 mg (AHCZ) in a double-blind, crossover, placebo-controlled study of 128 patients. Both drugs were given once daily. Atenolol produced a significant decline in lying, standing, and postexercise blood pressure and pulse rate values. The corresponding values on AHCZ were not significantly different from placebo. Both the beta-blocking agent and the thiazide diuretic with amiloride were relatively well tolerated. More than half of all adverse effects were nonspecific and also observed in patients on placebo. In the population studied, atenolol proved to be a superior antihypertensive agent to AHCZ. MICHAEL LISCHNER, M.D., is Senior Resident, Instructor in Medicine; RUTH LANG, M.D., is Physician, Lecturer in Medicine; ITZHAK JUTRIN, M.D., is Senior Physician; and MORDCHAI RAVID, M.D., is Head, Department of Medicine, Associate Professor of Medicine, Meir Hospital, Kfar Saba, and Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel.

A double-blind comparison of once-daily metoprolol controlled-release and atenolol in the treatment of Chinese patients with mild to moderate hypertension

1995 ◽  
Vol 9 (3) ◽  
pp. 401-406 ◽  
Author(s):  
Ming-Fong Chen ◽  
Chi-Yu Yang ◽  
Wen-Jone Chen ◽  
Chii-Ming Lee ◽  
Chau-Chung Wu ◽  
...  
Keyword(s):  
Controlled Release ◽  
Moderate Hypertension ◽  
Chinese Patients ◽  
Double Blind ◽  
Once Daily ◽  
Blind Comparison

scholarly journals A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Christine K. Bailey ◽  
Stephen Caltabiano ◽  
Alexander R. Cobitz ◽  
Chun Huang ◽  
Kelly M. Mahar ◽  
...  
Keyword(s):  
Dose Range ◽  
Hypoxia Inducible Factor ◽  
Conversion Ratio ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Once Daily ◽  
Human Erythropoietin ◽  
Dose Ranging ◽  
Baseline Hemoglobin

Abstract Background Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor currently being investigated as a treatment for anemia of chronic kidney disease (CKD) in both dialysis and nondialysis patients. In clinical studies to date, daprodustat has been administered orally as a once-daily regimen. This randomized, double-blind, placebo-controlled study characterized the initial dose-hemoglobin response as well as the efficacy and safety of three times weekly (TIW) daprodustat in hemodialysis patients switched from stable recombinant human erythropoietin (rhEPO), in accordance with a TIW hemodialysis schedule. Methods 103 patients on hemodialysis with baseline hemoglobin of 9.0 to 11.5 g/dL and previously receiving a stable dose of rhEPO or its analogs were randomized 1:1:1:1:1 to receive daprodustat 10, 15, 25, or 30 mg or placebo TIW over 29 days. Results Mean baseline hemoglobin was 10.6 g/dL for the placebo group and each daprodustat cohort. Daprodustat produced dose-dependent changes in mean hemoglobin from baseline to day 29. Using a Bayesian approach, the estimated dose conversion ratio between once-daily and TIW daprodustat was ~ 2.0 across the evaluated dose range using an Emax model. Daprodustat was generally well tolerated, with an adverse event (AE) profile consistent with the hemodialysis population. Conclusions These data help inform the appropriate dose conversion ratio to be applied to daily doses to obtain equivalent daprodustat TIW doses and suggest TIW treatment with daprodustat can treat anemia of CKD safely, supporting future long-term studies for this indication using a TIW dosing regimen. Trial registration ClinicalTrials.gov Identifier: NCT02689206; date registered: 02/11/2016.

Phase 3, randomized, double-blind, placebo-controlled study of venetoclax combined with azacitidine versus azacitidine in treatment-naïve patients with acute myeloid leukemia.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS7069-TPS7069 ◽  
Author(s):  
Jalaja Potluri ◽  
Tu Xu ◽  
Wan-Jen Hong ◽  
Mack H. Mabry
Keyword(s):  
Overall Survival ◽  
Myeloid Leukemia ◽  
Remission Rate ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Placebo ◽  
Treatment Naïve

TPS7069 Background: Elderly acute myeloid leukemia (AML) is a biologically and clinically distinct disease with a diminished response to chemotherapy, low remission rates, and short disease-free and overall survival. Venetoclax (VEN) is a potent, selective small-molecular inhibitor of BCL-2. In preclinical models, venetoclax has been shown to kill AML cells as a single agent with demonstrated synergistic activity in combination with the DNA methyltransferase inhibitor azacitidine (AZA). Early clinical data from a phase 1b study (NCT02203773) showed that VEN plus AZA had an acceptable safety profile and promising efficacy in treatment-naïve elderly patients with AML. The current phase 3 study continues to evaluate the combination for this AML population. Methods: This phase 3, randomized, double-blind, placebo-controlled study (NCT02993523) is designed to assess VEN plus AZA compared with placebo plus AZA in treatment-naïve elderly and adult patients with AML who are not eligible for standard induction therapy due to age or comorbidities. Primary objectives of the study are to evaluate if VEN with AZA will improve overall survival (OS) and composite complete remission rate (CR+CRi) versus placebo with AZA. Secondary objectives include event-free survival, CR+CRi rate at the end of Cycle 1, and if combining VEN plus AZA reduces fatigue and improves global health status/quality of life based on patient reported outcomes versus placebo with AZA. Exploratory objectives are to evaluate biomarkers predictive of VEN activity including minimal residual disease negativity rate, and BCL-2 expression and outcome measures of overall survival and complete remission rate, as well as the impact of VEN on additional quality of life measures. Patients will be randomized 2:1 to VEN plus AZA (arm A) or placebo plus AZA (arm B). Patients on arm A will receive once daily 400 mg VEN orally on days 1–28 plus daily 75 mg/m2 SC or IV AZA for 7 days in a 28-day cycle. Patients on arm B will receive once daily placebo orally on days 1–28 plus daily 75 mg/m2 SC or IV AZA for 7 days on a 28-day cycle. Study recruitment began in February 2017, with target enrollment of 400 patients. Clinical trial information: NCT02993523.

scholarly journals Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy

Blood ◽  
2006 ◽  
Vol 107 (5) ◽  
pp. 1785-1790 ◽  
Author(s):  
Christos Tsoukas ◽  
M. Elaine Eyster ◽  
Sumiko Shingo ◽  
Saurabh Mukhopadhyay ◽  
Karen M. Giallella ◽  
...  
Keyword(s):  
Global Assessment ◽  
Disease Status ◽  
Controlled Study ◽  
Pain Patient ◽  
Double Blind ◽  
End Points ◽  
Once Daily ◽  
Upper Respiratory Infection ◽  
Hemophilic Arthropathy ◽  
To Receive

This 2-part, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of etoricoxib, a COX-2 selective inhibitor, for the treatment of hemophilic arthropathy. In part 1 (6 weeks), 102 patients (≥ 12 years old) with hemophilic arthropathy were randomized to receive 90 mg etoricoxib once daily or placebo (1:1 ratio). In part 2 (6 months), 51 patients taking placebo in part 1 were randomized to receive 90 mg etoricoxib or 25 mg rofecoxib once daily; patients taking etoricoxib in part 1 continued the same treatment. Efficacy end points included Patient Assessment of Arthropathy Pain, Patient Global Assessment of Arthropathy Disease Status, and Investigator Global Assessment of Arthropathy Disease Status. Safety was evaluated at each study visit. Etoricoxib provided significant improvement in all end points versus placebo (P < .001). Fewer patients taking etoricoxib discontinued due to a lack of efficacy versus placebo (P = .048). During part 2, efficacy was maintained; etoricoxib and rofecoxib demonstrated similar results. The most common adverse experiences were upper respiratory infection and headache. The incidence of joint bleeding during part 1 was similar between etoricoxib (66.7%) and placebo (72.6%) and during part 2 between etoricoxib (77.0%) and rofecoxib (78.9%). We conclude that etoricoxib provided superior efficacy versus placebo for the treatment of hemophilic arthropathy and was generally safe and well tolerated.

Sign in / Sign up

Export Citation Format

Share Document