国产厄贝沙坦/氢氯噻嗪治疗原发性高血压疗效观察

目的评价国产厄贝沙坦/氢氯噻嗪对高血压患者的临床疗效。方法选择74例原发性高血压患者,日服1～2片厄贝沙坦/氢氯噻嗪,于4、8周前后观察24h动态血压监测结果。结果治疗4、8周后,24h平均血压下降26.74/14.46mmHg,31.82/18.25mmHg。结论国产厄贝沙坦/氢氯噻嗪日服1次对原发性高血压疗效确切。     

厄贝沙坦氢氯噻嗪治疗轻中度原发性高血压疗效观察

目的:观察厄贝沙坦氢氯噻嗪(厄贝沙坦150 mg/氢氯噻嗪12.5 mg复方制剂)治疗单用厄贝沙坦150 mg控制不良的轻中度高血压患者的疗效和安全性.方法:经厄贝沙坦150 mg 1次/日治疗4周,血压仍未正常(收缩压≥145 mmhg,舒张压≥95mmhg)的99例高血压患者随机分为两组,治疗组给于厄贝沙坦氢氯噻嗪1片,1次/日,对照组继续服用厄贝沙坦150 mg,1次/日,疗程8周.在治疗4周和结束时评估药物的安全性和有效性.结果:在轻中度高血压患者中厄贝沙坦氢氯噻嗪1片,天比单用厄贝沙坦150 mg/天血压下降达标率高.治疗结束时平均坐位收缩压降低4 mmHg,平均坐位舒张压下降2.5mmhg,血压控制<140/90mmHg的患者在厄贝沙坦氢氯噻嗪1片/天组和单用厄贝沙坦150 mg/天组分别为53.9%和40.9%.结论:轻中度原发性高血压患者采用厄贝沙坦氢氯噻嗪1片/天降压有效率及达标率优于厄贝沙坦150 mg/天组.厄贝沙坦氢氯噻嗪适用于厄贝沙坦单药控制不良的轻中度原发性高血压患者.     

厄贝沙坦/氢氯噻嗪治疗原发性高血压82例疗效观察

目的观察厄贝沙坦/氢氯噻嗪（依伦平）治疗原发性高血压的疗效。方法选择在我院住院及门诊就诊的原发性高血压患者163例,随机分为治疗组82例和对照组81例。治疗组口服厄贝沙坦/氢氯噻嗪片1片（每片含有厄贝沙坦150mg,氢氯噻嗪12.5mg）,每天1次。对照组口服厄贝沙坦片2片（每片含有厄贝沙坦75mg）,每天1次。如服药2周血压未达标者,药量加倍。2组患者均连续服药8周。结果治疗组总有效率为89.0%高于对照组的70.4%,差异有统计学意义（P〈0.05）。结论依伦平片治疗轻、中度（1～2级）高血压降压效果明显,不良反应少,依从性好,值得推广使用。     

厄贝沙坦氢氯噻嗪复方片治疗轻中度原发性高血压42例疗效观察

目的:观察单用厄贝沙坦与厄贝沙坦/氢氯噻嗪复方片(安博若)治疗1、2级原发性高血压的疗效和不良反应.方法:选取42例1、2级原发性高血压病人,随机分为两组.对照组口服厄贝沙坦每日1片;观察组口服厄贝沙坦/氢氯噻嗪复方片每日1片;两组疗程均为12周.观察两组降压疗效和不良反应.结果:观察组降压总有效率90.0%,对照组降压总有效率69.2%,两组比较差异有统计学意义(P＜0.05).两组病人不良反应轻微均能耐受.结论:厄贝沙坦/氢氯噻嗪复方片降压疗效确切,不良反应轻微,舒张压达标率高.     

厄贝沙坦氢氯噻嗪片治疗原发性高血压127例临床分析

目的 观察厄贝沙坦氢氯噻嗪片治疗原发性高血压的临床疗效.方法 选择符合标准的原发性高血压患者127例,随机分为A、B两组,A组65例,B组62例.A组口服厄贝沙坦150 mg氢氯噻嗪12.5 mg片开始,每日1次.B组口服厄贝沙坦片150 mg,每日1次.血压未达标者,2周后药量加倍.连续用药12周.观察两组降压疗效和...     

厄贝沙坦氢氯噻嗪片治疗原发性高血压的疗效观察

目的比较厄贝沙坦氢氯噻嗪片与厄贝沙坦治疗轻、中度原发性高血压的临床疗效。方法将lOO傩者随机分为2组：观察组50例,厄贝沙坦氢氯噻嗪片（含厄贝沙坦150mg,氢氯噻嗪12．5mg）,1片／d;对照组50例,厄贝沙坦150mg／d。用药4周后进行疗效分析。结果观察组总有效率为98％,对照组总有效率为80％,2组比较差异有统计学意义（P〈0．05）。结论厄贝沙坦氢氯噻嗪片治疗轻、中度原发性高血压疗效优于单独使用厄贝沙坦。     

厄贝沙坦联合氢氯噻嗪治疗老年高血压38例临床效果分析

目的 探讨厄贝沙坦和氢氯噻嗪联用治疗老年高血压的临床效果及安全性.方法 将门诊治疗的76例老年高血压患者随机分为观察组和对照组各38例,观察组口服厄贝沙坦氢氯噻嗪片(含厄贝沙坦150 mg,氢氯噻嗪12.5 mg),对照组口服厄贝沙坦150 mg,每日1片,4周1个疗程,观察两组用药前后各类指标变化及降压效果.结果 用药12周后,两组患者血压均较治疗前明显下降,治疗前后比较差异有统计学意义(P ＜ 0.05);治疗后两组血压比较差异无统计学意义(P ＞ 0.05);观察组治疗的总有效率明显高于对照组,且不良反应发生率明显低于对照组,两组比较差异均具有统计学意义(P ＜ 0.05).结论 厄贝沙坦联合氢氯噻嗪治疗老年高血压疗效确切,耐受性好,无明显不良反应,值得临床推广应用.     

厄贝沙坦-氢氯噻嗪片对原发性高血压患者血尿酸的影响

目的观察厄贝沙坦-氢氯噻嗪片对原发性高血压患者血尿酸的影响。方法原发性高血压患者29例服用厄贝沙坦-氢氯噻嗪片1片,qd,共8 wk。观察治疗前后血压及血尿酸的变化,并与15例服用氯沙坦50mg.d-1、15例服用厄贝沙坦50mg+氢氯噻嗪≥12.5 mg.d-1超过8 wk的同期住院的原发性高血患者的血压、血尿酸进行比较。结果①厄贝沙坦-氢氯噻嗪片治疗后血压降低明显,与治疗前比P<0.01,与氯沙坦组及氯沙坦加氢氯噻嗪组降压效果相当;②厄贝沙坦-氢氯噻嗪片治疗后尿酸降低,但与治疗前比较无差异(P>0.05);而与单用氯沙坦及氯沙坦加氢氯噻嗪组比较尿酸降低有显著差异(P<0.01)。氯沙坦组与氯沙坦加氢氯噻嗪组比较,尿酸有降低趋势但无统计学意义。结论厄贝沙坦-氢氯噻嗪片降低原发性高血压患者血尿酸浓度比氯沙坦加氢氯噻嗪效果明显。     

厄贝沙坦氢氯噻嗪复方片治疗高血压病76例疗效观察

目的探讨厄贝沙坦氢氯噻嗪复方片治疗原发性高血压的临床疗效。方法选择符合标准的原发性高血压患者76例,随机分为A、B两组,每组各38例。A组口服厄贝沙坦150mg／氢氯噻嗪12．5mg复方片开始,每日1次。B组口服厄贝沙坦片150mg,每日1次。血压未达标者,2周后药量加倍。连续用药8周并监测血压。结果A组与B组总有效率分别为89％与63％,两组比较,差异有显著性（P〈0．05）。结论厄贝沙坦氢氯噻嗪复方片治疗原发性高血压疗效明显优于单用厄贝沙坦组,且不良反应少。     

厄贝沙坦与厄贝沙坦氢氯噻嗪治疗糖尿病合并高血压的疗效比较

目的：评价厄贝沙坦与厄贝沙坦氢氯噻嗪对糖尿病合并高血压患者的疗效。方法选取2010年1月-2011年11月于我院门诊及住院治疗的糖尿病合并高血压患者70例,随机分为两组：A组（厄贝沙坦组,36例）口服厄贝沙坦片,1片/d;B组（厄贝沙坦氢氯噻嗪组,32例）口服厄贝沙坦氢氯噻嗪胶囊,1粒/d。4周后未达标者增加剂量1片（粒）/次,2次/d,6个月结束。结果降压效果B组优于A组（P〈0.05）。两组治疗前后的血糖、血脂及血钾浓度均差异无统计学意义。结论厄贝沙坦氢氯噻嗪比厄贝沙坦能更好地控制患者的血压,对血糖、血脂及血钾均无影响。     

Irbesartan/Hydrochlorothiazide : in moderate to severe hypertension

* The fixed-dose combination of irbesartan/hydrochlorothiazide (HCTZ) is approved in the US for use as initial therapy in patients who are likely to need multiple agents to achieve their blood pressure (BP) goals. * In a 12-week, randomized, double-blind, multicentre trial in 538 patients with moderate hypertension that was untreated or uncontrolled by monotherapy, the mean reduction from baseline in seated systolic BP (SeSBP) at week 8 (primary endpoint) was significantly greater with irbesartan/HCTZ than with either irbesartan or HCTZ as monotherapy. * In addition, the proportion of patients with moderate hypertension achieving controlled BP (SeSBP < 140 mmHg/seated diastolic BP [SeDBP] < 90 mmHg) at 12 weeks was significantly greater with irbesartan/HCTZ combination therapy than with irbesartan or HCTZ monotherapy. * In a 7-week, randomized, double-blind, multicentre trial in 697 patients with severe hypertension that was untreated or uncontrolled by monotherapy, a significantly greater proportion achieved a trough SeDBP of < 90 mmHg following 5 weeks of combination therapy with irbesartan/HCTZ compared with irbesartan monotherapy (primary endpoint). * Furthermore, the proportion of patients with severe hypertension achieving controlled BP of < 140/90 mmHg was significantly greater at all timepoints of the trial compared with irbesartan monotherapy. * Irbesartan/HCTZ combination therapy had a similar tolerability profile to irbesartan and HCTZ monotherapy. Most adverse events were of mild to moderate intensity.     

Aliskiren: a review of its use in the management of hypertension

Aliskiren (Tekturna) is an orally active, nonpeptidic inhibitor of renin, the enzyme involved in the initial and rate-limiting step of the renin-angiotensin system (RAS). In the US, aliskiren is approved for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents.Monotherapy with aliskiren 150-300mg once daily was effective in lowering blood pressure (BP) and providing 24-hour BP control; it was generally well tolerated when administered for up to 1 year to patients with mild to moderate hypertension. In the short term (1-3 months), the BP-lowering effect of aliskiren 150-300mg once daily was significantly greater than that of hydrochlorothiazide (HCTZ) 12.5-25mg once daily and noninferior to, or significantly greater than, that of ramipril 5-10mg once daily. It was similar to that of valsartan 160-320mg once daily and losartan 100mg once daily, and similar to, or significantly greater than, that of irbesartan 150mg once daily. Aliskiren provided significant additional BP-lowering effects when combined with HCTZ 12.5-25 mg/day, ramipril 5-10 mg/day, amlodipine 5mg once daily or valsartan 160-320 mg/day; combination therapy was well tolerated. Long-term administration of aliskiren-based therapy was superior to HCTZ- and ramipril-based therapies in lowering BP after 6 months, and was similarly well tolerated.The ultimate role of aliskiren will be determined by the results of target organ protection studies, which are ongoing, and a cardiovascular outcome trial, which is planned. Nonetheless, by offering a new approach to the blockade of the RAS, aliskiren provides a useful addition to the therapeutic options available to treat patients with mild to moderate hypertension.     

Efficacy and Safety Study of Olmesartan Medoxomil,Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized,Double-Blind,Multicenter Trial

Background

This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20  mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5).

Methods

In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period.

Results

A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were ?9.50 (8.46) mmHg in the OM/AML/HCTZ group and ?4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated.

Conclusion

In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

     

厄贝沙坦与厄贝沙坦／氢氯噻嗪复方制齐佾疗轻中度原发性高血压的疗效对比观察

目的评价厄贝沙坦与厄贝沙坦／氢氯噻嗪复方制剂治疗高血压病的疗效。方法轻中度原发性高血压患者共106例,随机分为两组,一组为厄贝沙坦治疗组（n=52）,服用厄贝沙坦150mg,1次／日;另一组为厄贝沙坦／氢氯噻嗪复方制剂组（n=54）,服用厄贝沙坦150rng和氢氯噻嗪12．5mg的复方制剂,1次／日。结果治疗12周后．厄贝沙坦／氢氯噻嗪复方制剂降压的总有效率为83．3％（45／54）,厄贝沙坦降压的总有效率为78．8％（41／52）,两组血钾、LDL-C、血糖较入组时无明显变化,组间差异无统计学意义,未观察到严重不良反应。结论厄贝沙坦／氢氯噻嗪复方制剂治疗轻中度原发性高血压患者的控制率和达标率较高．较单用厄贝沙坦未增加不良反府．     

Once vs twice daily administration of a fixed combination of captopril plus hydrochlorothiazide in essential hypertension: a double-blind crossover study in known responders to a standard combination.

The purpose of this randomized, double-blind, crossover trial was to compare the hypotensive effects of a fixed combination of captopril (C) 50 mg and hydrochlorothiazide (HCTZ) 25 mg (C 50/HCTZ 25) once daily with those of a fixed combination of C 25 mg and HCTZ 12.5 mg (C 25/HCTZ 12.5) twice daily. We studied 199 patients (108 M, 91 F) with mild to moderate essential hypertension whose BP was already controlled by the co-administration of C 25 mg and HCTZ 12.5 mg twice daily. They were randomly assigned to either C 25/HCTZ 12.5 twice daily during the first 6 weeks and C 50/HCTZ 25 once daily during the second 6 weeks or C 50/HCTZ 25 once daily followed by C 25/HCTZ 12.5 twice daily. Both regimens showed comparable efficacy on office diastolic BP (91.6 vs 91.3 mm Hg). Systolic BP was slightly but significantly higher (P = 0.02) with the once daily formulation (141.2 vs 139.1 mm Hg). Fixed combinations once daily and twice daily resulted in identical working ambulatory BP (133.7 +/- 13/83.6 +/- 8 mm Hg vs 132.4 +/- 11/83.3 +/- 7 mm Hg) without affecting heart rate. Adverse events were reported by 16% of patients and cough was the most common occurring in 7%. In conclusion, these results indicate that the fixed combination of C 50/HCTZ 25 given once daily controls office and working BP as well as the fixed combination C 25/HCTZ 12.5 given twice daily in patients with mild to moderate hypertension.     

厄贝沙坦与氢氯噻嗪联合治疗原发性高血压的疗效和安全性评价

目的 :观察厄贝沙坦(国产)与氢氯噻嗪治疗1、2级原发性高血压的疗效和安全性。方法 :73例1、2级原发性高血压患者随机分成两组 ,分别服用厄贝沙坦150mg日1次与氢氯噻嗪12 5mg日1次和卡托普利25mg日3次与氢氯噻嗪12 5mg日1次 ,治疗4周。观察用药前后血压、心率变化 ,记录患者用药的不良反应 ,结合实验室检查作安全性评价。结果 :两组治疗前后相比 ,血压下降差异有非常显著性(P<0 01)。厄贝沙坦组总有效率为80 6% ,卡托普利组为77 1% ,两组间比较差异无显著性(P>0 05) ,但药物相关不良反应前者显著低于后者(P<0 05)。结论 :厄贝沙坦与氢氯噻嗪联合应用治疗1、2级原发性高血压疗效确切 ,患者耐受性和安全性较好     

Aliskiren: a review of its use as monotherapy and as combination therapy in the management of hypertension

Aliskiren is an orally administered, nonpeptide direct renin inhibitor indicated for the management of hypertension. Aliskiren was effective in controlling blood pressure (BP) as monotherapy and in combination with other antihypertensives, in large, randomized trials. Aliskiren 150-300?mg/day as monotherapy was effective in lowering BP across short- (≤12 weeks) and longer-term (up to 54 weeks) periods, providing sustained and consistent effects with 24-hour BP control. Compared with other antihypertensives, aliskiren was generally as effective as hydrochlorothiazide (HCTZ), valsartan, losartan, irbesartan and lisinopril in reducing BP. Furthermore, short-term aliskiren was noninferior to ramipril in reducing BP, but with a longer treatment duration, a greater efficacy of aliskiren-based therapy over ramipril-based therapy was demonstrated. Additional BP-lowering effects occurred when aliskiren was coadministered (as a fixed-dose combination or separate tablets) with other antihypertensives, including HCTZ, valsartan and amlodipine, according to large, randomized trials of short- (≤12 weeks) and longer-term (up to 54 weeks) duration. Combination therapy with aliskiren plus HCTZ was effective in hypertensive patients when administered as initial therapy or to patients previously treated with HCTZ or aliskiren monotherapy. Aliskiren-based therapy was also effective in lowering BP in obese patients, patients with type 1 or 2 diabetes mellitus, patients with metabolic syndrome and the elderly. Aliskiren efficacy was observed irrespective of patient age, sex or ethnicity. Aliskiren monotherapy or combination therapy was generally well tolerated over short- and longer-term study durations in large, randomized clinical trials. Clinical trials to evaluate the effects of aliskiren on clinical outcomes, including renoprotective and cardioprotective effects, are currently ongoing. Thus, aliskiren is a useful option for the treatment of patients with stage 1 to stage 2 (mild to moderate) hypertension, alone or in combination with other antihypertensives, including HCTZ, valsartan or amlodipine.     

Effects of valsartan versus olmesartan addition to amlodipine/hydrochlorothiazide combination in treating stage 2 hypertensive patients

Objective: The objective of this study was to assess the effects of valsartan or olmesartan addition to dual therapy with amlodipine + hydrochlorothiazide (HCTZ) in the treatment of stage 2 hypertension.

Research design and methods: 180 patients with diastolic blood pressure (DBP) ≥ 99 and < 110 mm Hg were treated with amlodipine 5 mg + HCTZ 12.5 mg combination. After 4 weeks, 149 patients whose blood pressure (BP) was not controlled, were randomized to the combination of valsartan 160 mg + amlodipine 5 mg + HCTZ 12.5 mg or olmesartan 20 mg + amlodipine 5 mg + HCTZ 12.5 mg for 4 weeks.

Main outcome measures: At the end of each period, clinical and ambulatory BP measurements were recorded.

Results: Both triple combinations produced greater ambulatory and clinical SBP/DBP reduction than dual therapy. However, mean reduction from baseline in the valsartan + amlodipine + HCTZ-treated patients was significantly greater than in the olmesartan + amlodipine + HCTZ-treated patients. Compared with dual therapy, the add-on effect of valsartan was significantly greater than that of olmesartan, the difference being more evident for nighttime SBP/DBP values (-3.3 (95% CI 0.44 – 3.51)/3.0 (95% CI 0.59 – 3.34) mm Hg, p < 0.01).

Conclusions: The addition of valsartan to amlodipine + HCTZ produced greater BP reduction than the addition of olmesartan.     

Effect of three months' treatment with irbesartan on blood and pulse pressure of hypertensive type 2 diabetic patients: open, observational study in 31,793 patients

OBJECTIVES: In hypertensive diabetics the cardiovascular risk is substantially increased. Therefore, an effective reduction of both blood pressure and pulse pressure is of particular importance for these patients. The aim of the prospective observational study in hypertensive type 2 diabetics was to assess the effect of a switch from the previous antihypertensive therapy to the angiotensin-II-receptor antagonist irbesartan (alone or in combination with HCTZ) on the reduction of blood pressure and pulse pressure, the reduction of diabetic nephropathy (microalbuminuria), and tolerability. METHODS: 8714 general practitioners included 31,793 type 2 diabetics aged at least 18 years in an open observational study. After inclusion in to the study the patients received irbesartan 300 mg as monotherapy or in combination with hydrochlorothiazide 12.5 mg (HCTZ). Main outcome measures for efficacy were the reduction of systolic (SBP) and diastolic (DBP) blood pressures, reduction of pulse pressure, and blood pressure responder (reduction in DBP > or = 10 mmHg or diastolic < 90 mmHg), diastolic normalization (DBP < 90 mmHg) and overall normalization rates (SBP < 140 mmHg and DBP < 90 mmHg) after 3 months. Further outcome measures included the reduction of microalbuminuria or proteinuria, and adverse events (AEs) as a measure of tolerability. RESULTS: Thirty-eight per cent of patients received irbesartan 300 mg and 61% irbesartan in combination with HCTZ. Mean systolic blood pressure was reduced by 22.5 mmHg, diastolic blood pressure by 10.7 mmHg (baseline values: 160.2 and 93.2 mmHg). Pulse pressure fell on average by 11.6 mmHg. 83.4% of the patients were responders, with an overall normalization rate of 42.7% (SBP < 140 mmHg and DBP < 90 mmHg), respectively 73.8% (DBP < 90 mmHg). The antihypertensive benefit was achieved irrespective of the previous medication. Mean albuminuria decreased by about 27.7 mg/L. Only 0.3% of patients experienced adverse events. CONCLUSIONS: In type 2 diabetics with hypertension and either uncontrolled or no previous antihypertensive therapy a change to treatment with irbesartan or irbesartan/HCTZ for 3 months resulted in a distinct reduction of systolic and diastolic blood pressures, with concomitant effective reductions of pulse pressure and microalbuminuria.     

Efficacy and safety of triple antihypertensive therapy with the olmesartan/amlodipine/hydrochlorothiazide combination

Background: European hypertension guidelines estimate that up to 15-20% of hypertensive patients are not controlled on a dual antihypertensive combination and require three or more different antihypertensive drug classes to achieve blood pressure (BP) control. Objective: This study in patients with moderate-to-severe hypertension assessed the efficacy and safety of adding hydrochlorothiazide (HCTZ) 12.5?mg and 25?mg to a range of olmesartan medoxomil (OLM)/amlodipine (AML) doses. Study Design: This phase III, multicentre study had a randomized, double-blind, parallel-group design that included a double-blind safety run-in and a double-blind treatment period. Intervention: Enrolled patients were screened and previous therapy was discontinued if required. During a 2-week, double-blind, safety run-in period (Weeks 0-2), patients were randomized to receive placebo, OLM/AML 20?mg/5?mg, OLM/AML 40?mg/5?mg or OLM/AML 40?mg/10?mg. During an 8-week, double-blind treatment period (Weeks 3-10), patients were allocated to eight groups depending on their initial treatment. They were either randomized to continue with the same dose of OLM/AML, or have HCTZ 12.5?mg or 25?mg added to treatment. Main Outcome Measure: The primary endpoint was formulated before data collection began. It was the change in mean diastolic BP (DBP) from baseline to Week 10 in groups with HCTZ added to OLM/AML, compared with the corresponding dual OLM/AML therapy. Results: Of 3195 patients who were screened, 2690 were randomized. Patients in every triple OLM/AML/HCTZ group had significantly greater mean reductions in DBP (p?≤?0.032 for each comparison) and systolic BP (SBP) by Week 10 (p?≤?0.0034 for each comparison), compared with patients on the corresponding OLM/AML therapy dose. The significant improvements in DBP and SBP reduction with triple OLM/AML/HCTZ therapy, compared with dual OLM/AML therapy, were observed after 4 and 6 weeks of therapy. Patients in each triple therapy group also had a significantly higher rate of BP <140/90?mmHg threshold achievement (p?≤?0.05 for each treatment comparison), compared with the dual OLM/AML groups. In three of the OLM/AML/HCTZ groups (40?mg/5?mg/25?mg, 40?mg/10?mg/12.5?mg and 40?mg/10?mg/25?mg), BP <140/90?mmHg threshold achievement by Week 10 was over 70%. Across the triple and dual combination therapy groups, treatment was well tolerated and no safety concerns for either treatment were identified. Conclusion: Adding HCTZ to a range of OLM/AML dose combinations is well tolerated and improved BP control by significantly lowering DBP and SBP and significantly increasing BP threshold achievement in patients with moderate-to-severe hypertension. Clinical Trial Registration: Registered at ClinicalTrials.gov identifier as NCT00923091.