Clinical trial NCT01176032
Conditions: Hypertension Left Ventricle Hypertrophy
Keywords: Aliskiren hypertension concentric LVH LV remodeling LVMI biomarkers PICP CT-1 MMP-1 TIMP-1 AnxA5 Aldosterone Essential hypertension with concentric left ventricle hypertrophy
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2013-04-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.

Detailed description:
Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (\<140/90 mmHg).

The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\<140/90 mmHg), the dose of amlodipine was increased to 10 mg.

Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed

Arms: arm 1: Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (\<140/90 mmHg) was still not achieved.

HCTZ 12.5mg was prescribed at week 26 if the required values (\<140/90 mmHg) had not been reached. arm 2: Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (\<140/90 mmHg) was still not achieved.

HCTZ 12.5mg was prescribed at week 26 if the required values (\<140/90 mmHg) had not been reached.
Interventions: intervention 1: Aliskiren intervention 2: Losartan intervention 3: Amlodipine intervention 4: Hydrochlorothiazide (HCTZ)
Intervention descriptions: intervention 1: Aliskiren 300 mg film coated tablets intervention 2: Losartan 100 mg tablets intervention 3: Amlodipine 5mg was given to patients who did not achieve the required blood pressure (\<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (\<140/90 mmHg) was still not achieved. intervention 4: HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (\<140/90 mmHg) had not been reached.

Protocol documents: