Conditions: Essential Hypertension
Keywords: Moderate systolic hypertension - adults - aliskiren -ramipril
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 506
Healthy volunteers: no

Brief summary:
This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

Detailed description:

Arms:
arm 1: In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.

In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.

In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4). arm 2: In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.

In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.

In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4). arm 3: In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4). arm 4: In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Interventions: intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Matching placebo to Aliskiren intervention 4: Matching placebo to Ramipril
Intervention descriptions: intervention 1: 150 mg Aliskiren as film-coated tablet intervention 2: Ramipril 5 mg was given in capsule form. intervention 3: The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm. intervention 4: The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Protocol document: