Conditions: Hypertension Stage 2 Hypertension Diabetes
Keywords: High blood pressure diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 975
Healthy volunteers: no

Brief summary:
This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

Detailed description:

Arms:
arm 1: At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks. arm 2: At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks. arm 3: At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.

Interventions: intervention 1: Valturna intervention 2: Amlodipine intervention 3: Chlorthalidone intervention 4: Placebo of Valturna Tablet intervention 5: Placebo Capsule
Intervention descriptions: intervention 1: Valturna (aliskiren 150 mg/valsartan 160 mg) tablet intervention 2: Amlodipine 5 mg and 10 mg capsule intervention 3: Chlorthalidone 15 mg and 25 mg capsule intervention 4: Matching placebo of valturna tablet intervention 5: Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Protocol document: