Efficacy and Tolerability of Telmisartan Plus Amlodipine in Asian Patients Not Adequately Controlled on Either Monotherapy or on Low-Dose Combination Therapy

Table 1

Details of included trials.

	A5 nonresponder study 1	A5 nonresponder study 2	T40 nonresponder study	T80 nonresponder study	Nonresponder to low-dose T/A combination study
Trial identifier	NCT00558064	NCT01103960	NCT00550953	NCT01222520	NCT01286558
Reference	Data on file	Zhu et al [28]	Data on file	Data on file	Data on file
Trial duration	October 10, 2007–September 27, 2008	July 28, 2010–August 27, 2011	October 15, 2007–July 19, 2008	October 23, 2010–June 18, 2011	January 22, 2011–October 15, 2011
Study sites	41 sites in Japan	16 investigative sites—12 sites in the People's Republic of China, 2 sites in Malaysia, and 2 sites in Philippines	5 sites in Japan	4 sites in Japan	8 sites in Japan
BP inclusion criteria, start of open-label run-in period	DBP ≥95 and ≤114 mm Hg; SBP ≥140 and ≤200 mm Hg	DBP ≥95 if on antihypertensive treatment, or ≥100 mm Hg if treatment is naïve	DBP ≥95 and ≤114 mm Hg; SBP ≥140 and ≤200 mm Hg	DBP ≥90 and ≤114 mm Hg in patients on antihypertensive drugs; DBP ≥95 and ≤114 mm Hg in treatment-naïve patients; SBP ≥140 and ≤200 mm Hg	DBP ≥90 and ≤114 mm Hg in patients on antihypertensive drugs; DBP ≥95 and ≤114 mm Hg in treatment-naïve patients; SBP ≤200 mm Hg
BP inclusion criteria, start of 8-week double-blind treatment period	DBP ≥90 and ≤114 mm Hg; SBP ≤200 mm Hg	DBP ≥90 mm Hg	DBP ≥90 and ≤114 mm Hg; SBP ≤200 mm Hg	DBP ≥90 and ≤114 mm Hg; SBP ≤200 mm Hg	DBP ≥80 and ≤114 mm Hg; SBP ≤200 mm Hg
BP exclusion criteria	SBP/DBP >200/>114 mm Hg at screening, at the start of the open-label run-in period or double-blind treatment period; SBP/DBP >200/>114 mm Hg or DBP <90 mm Hg, 2 weeks after the start of the open-label run-in period	BP ≥ 200/120 mm Hg at screening or during the run-in period; ≥180/120 mm Hg at the end of the run-in period	SBP/DBP >200/>114 mm Hg at screening, at the start of the open-label run-in period or double-blind treatment period; DBP <90 mm Hg at the start of the open-label run-in period
Duration and treatment during open-label run-in period	A5 once daily for 6 weeks	A5 once daily for 6 weeks	T20 once daily for 2 weeks then T40 once daily for 4 weeks	T20 for 2 weeks; T40 for 2 weeks; T80 for 4 weeks	T20 for 2 weeks; T40 for 4 weeks; T40/A5 6 weeks
𝑁, run-in period	636	381	357	197	292
Duration of double-blind period	8 weeks	8 weeks	8 weeks	8 weeks	8 weeks
Double-blind treatment groups	A5; T20 + A5 for 2 weeks; T40/A5 SPC for 6 weeks	A5; T80/A5 SPC	T40; T40/A5 SPC	T80; T80/A5 SPC	T40/A5 SPC; T80/A5 SPC
𝑁, randomized groups	262; 269	164; 160	158; 156	87; 87	113; 112

A5: amlodipine 5 mg; BP: blood pressure; DBP: diastolic blood pressure; NCT: National Clinical Trial; SBP: systolic blood pressure; SPC: single-pill combination; T20: telmisartan 20 mg; T40: telmisartan 40 mg; T80: telmisartan 80 mg; T/A: telmisartan plus amlodipine.
DBP and SBP are mean seated values.