Abstract: Objective To evaluate the effectiveness and safety of sublingual nifedipine controlled release of formulation（sub-Ni-f GITS） 30 mg in patients with moderate and severe hypertension. Methods Patients with systolic blood pressure（SBP）≥175 mm Hg, or SBP≥160 mm Hg and headache who visited outpatient department from August 2018 to May 2019 were included. Firstly, a randomized, placebo-controlled, single blind study was conducted, in which 69 patients were divided into 3 groups（n=23）: control group（placebo）, Baixintong（BXT） group（Ni-f preparation of Bayer company） and Xinran（XR） group（Ni-f preparation of Xiandai company）. Then 144 patients were divided to BXT group（n=72） and XR group（n=72） to compare the safety and effectiveness of the preparations. Blood pressure（BP） and pulse rate（represent for heart rate, HR） were measured at the 5^th, 10^th, 15^th, and 20^th minutes after intervention. And BP and HR reductions（ΔBP and ΔHR） and reduction ratios were calculated. ΔBP or reduction of mean arterial pressure（ΔMAP）＞10% at the 20^th minute was defined as effective. ΔMAP≤25% or SBP≥140 mm Hg with ΔHR≤10 at the 20^th minute, or no complain of palpitation and dizziness during the observation were defined as safe. Results In placebo-controlled study, age, gender, medical history of hypertension, baseline SBP, diastolic blood pressure（DBP）, mean arterial pressure（MAP） and HR were comparable in 3 groups. SBP started to drop 5 minutes after intervention in BXT and XR group, and significantly decreased at the 20^th minute （159.6±9.6） vs（182.0±4.7）mm Hg,（164.5±13.4） vs（184.0±7.8）mm Hg, both P＜0.05, while did not significantly decrease in control group （177.7±12.2） vs（182.7±9.4）mm Hg, P=0.154. Reduction ratios of MAP were 7.3%, 7.7% and 1.7% respectively. HR did not significantly change after intervention in 3 groups. In case-control study, patients in both groups had comparable gender, mean age, medical history of hypertension, calcium channel blocker（CCB） useage and reduction ratios of SBP and MAP 20 minutes after sublingual nifedipine treatment. Five patients had SBP＜140 mm Hg during the observation, with one SBP 130 and others ＞135 mm Hg. One patient’s HR increased from 88.5 to 104.0 beats/min. During observation, 10 patients had SBP reductions＜5 mm Hg, 6 of whom had SBP slightly increased. Conclusions Sublingual 30 mg Ni-f GITS can effectively reduce SBP and MAP without adverse reactions for hypertensive patients with significantly increased SBP. Baixintong and Xinran had similar effectiveness and safety.