This 16-week trial investigated the efficacy and safety of single-pill valsartan/hydrochlorothiazide (HCTZ) vs the individual components in patients 70years and older with systolic hypertension. Patients were randomized to valsartan/HCTZ 160/12.5mg (n=128), HCTZ 12.5mg (n=128), or valsartan 160mg (n=128) for 4weeks. Patients whose blood pressure (BP) was ≥140/90mmHg at weeks 4, 8, or 12 were up-titrated to a maximum of valsartan/HCTZ 320/25mg. Week 4 systolic BP reduction (primary efficacy outcome) was greater with valsartan/HCTZ than valsartan (-17.3mmHg vs -8.6mmHg, P<.0001) but only marginally greater than HCTZ (-13.6mmHg, P = .096). Median time to BP control was shorter with valsartan/HCTZ (4weeks) vs HCTZ (8weeks, P<.05) or valsartan (12weeks, P<.0001). Thiazide monotherapy was more effective than angiotensin receptor blocker monotherapy (by about 5mmHg), but greater antihypertensive efficacy was achieved by initiating treatment with combination valsartan/HCTZ in the elderly.