OBJECTIVES:  To compare clinical and patient-reported outcomes of OM/AML/HCT triple combination of different dose strengths with that of respective double combination in hypertensive patients. METHODS: The study (CS8635-A-E302) was a randomised, double-blind, parallel-group study, multi-centre, European, phase III clinical trial evaluating the efficacy and safety of co-administration of triple combinations OM/AML/HCT directly compared with the corresponding double combination of OM/AML in subjects with hypertension. The following five pairwise treatment group comparisons were considered after 10 weeks: A) OM20/AML5/HCT12.5mg vs. OM20/AML5; B) OM40/AML5/HCT12.5mg vs. OM40/AML5; C) OM40/AML5/HCT25mg vs. OM40/AML5; D) OM40/AML10/HCT12.5mg vs. OM40/AML10; E) OM40/AML10/HCT25mg vs. OM40/AML10. Primary clinical outcome was the responder rate defined as percentage of subjects achieving blood pressure goal (<140/90 mmHg; <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease). The number-needed-to-treat (NNT) was calculated. Patient reported outcomes (PRO) were recorded on two quality-of-life (QoL) instruments, EQ-5D and MINICHAL.  RESULTS: Overall, 2690 patients (mean age: 56.5±10.5 years; 53.6% female) were followed over 10 weeks, balanced in each treatment group. Responder rate was higher in triple treatment groups compared to respective dual combination: A) 53.0% versus 42.7%, p<0.05, NNT 10 patients; B) 52.4% versus 46.4%, NNT 17 patients; C) 58.8% versus 46.4%, p<0.05, NNT 9 patients; D) 56.5% versus 49.6%, NNT 15 patients; E) 53.9% versus 49.6%, NNT 23 patients. Whereas patients reported statistically significant intra-individual improvements for most of the treatment regimens (mean improvement ranged from 0.007 to 0.026 (EQ-5D utility score) and from -1.2 to -1.7 (MINICHAL), the 10-week change in QoL was not significantly different between treatment groups of triple and the respective dual combination. CONCLUSIONS: Overall, responder rates are superior in patients receiving triple combination OM/AML/HCT in comparison to the respective dual combination OM/AML. Although the triple combination contains a further agent this had no negative impact on QoL.