Treatment with aliskiren/amlodipine combination in patients with moderate-to-severe hypertension: a randomised, double-blind, active comparator trial


  • Disclosures This study was supported by Novartis Pharma AG. Jack Zhang, Sashka Hristoskova, and Dieter A. Häring are employees of Novartis and are therefore eligible for Novartis stock and stock options. Ruediger C. Braun-Dullaeus, Sergey B. Shustov, Carmen Alvarez and Gregorio G Rogelio have received research support from Novartis and have acted as consultants for Novartis.

  • Clinical trial registration number: NCT00841672 on

Prof. Ruediger C. Braun-Dullaeus, Internal Medicine/Cardiology, Angiology, and Pneumology, Otto-von-Guericke-University Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany
Tel.: +49 391 6713201
Fax: +49 391 6713202


Aims:  To assess the extent of reduction in blood pressure (BP) of aliskiren/amlodipine combination therapy compared with amlodipine monotherapy in moderate-to-severe hypertensive patients.

Methods:  This was an 8-week multicentre, randomised, double-blind study. After a 1-to 4-week washout period, eligible patients [mean sitting systolic blood pressure (msSBP) ≥ 160 to < 200 mmHg] were randomised to receive a once-daily dose of aliskiren/amlodipine 150/5 mg (= 244) or amlodipine 5 mg (= 241) for 1 week, followed by up-titration to aliskiren/amlodipine 300/10 mg or amlodipine 10 mg for 7 weeks. Efficacy outcome measures included change from baseline to week 8 endpoint in msSBP (primary endpoint), mean sitting diastolic blood pressure (msDBP), and BP control rate (< 140/90 mmHg). Safety was assessed by monitoring and recording all adverse events (AEs) and laboratory abnormalities.

Results:  Patients’ demographic characteristics were balanced between the two groups, mean baseline BP being 171.0/94.3 mmHg for aliskiren/amlodipine and 171.8/95.6 mmHg for amlodipine. Of 485 randomised patients, 433 (89.3%) completed the study. At week 8 endpoint, combination therapy resulted in significantly greater msSBP/msDBP reductions and BP control rate, compared with monotherapy (all: p ≤ 0.0001). The overall incidence of AEs was similar between the two groups. The most commonly reported AE was peripheral oedema with the incidence lower for combination therapy (14.4%) than for monotherapy (18.3%).

Conclusion:  In this population with considerably elevated BP, use of aliskiren/amlodipine combination showed significantly greater BP reductions and allowed more patients to achieve BP control compared with amlodipine monotherapy, with no additional safety concerns.