| Reference (Year) | Study Design, Duration, Setting, BP measurement, No of patients | Demographics and Baseline Characteristicsa | Daily Treatment Regimens | Primary End Point | Quality Scoreb |
|---|---|---|---|---|---|
| Villamil (2007) [21] | Randomized, double-blind, placebo-controlled, multicenter; 8 wks; clinic; trough BP; n=2776 | Age ≥ 18 yrs. Eligibility for single-blind phase: msDBP ≥95 and <110 mmHg (baseline). Eligibility for double-blind phase: msDBP ≥95 and <110 mmHg after 2 or 4 wks on placebo. Mean age 55 yrs; 55% men; 86% Caucasian. | Single-blind, placebo run-in period (2 wks or 4 wks): Placebo. Double-blind treatment (8 wks): Placebo; Aliskiren 75, 150, 300mg; HCTZ 6.25, 12.5, 25mg; Aliskiren/HCTZ 75/6.25, 75/12.5, 75/25, 150/6.25, 150/12.5, 150/25, 300/12.5, 300/25mg. |
Change in msDBP from baseline (start of double-blind treatment) to wk 8 endpoint (aliskiren monotherapy vs placebo; combination therapy vs respective monotherapies) | 60%c |
| Jordan (2007) [22] | Randomized, double-blind, multicenter; 12 wks; clinic; trough BP; n=489 | Age ≥ 18 yrs. Eligibility for single-blind phase: msDBP ≥95 and <110 mmHg (baseline). Eligibility for double-blind phase: msDBP ≥90 and <110 mmHg. BMI ≥ 30 kg/m2; Mean age 54 yrs; 44% men; 99.6% Caucasian. | Single-blind treatment (4 wks): HCTZ 25mg. Double-blind treatment (first 4 wks – next 8 wks): Placebo–HCTZ 25 – 25mg; Aliskiren/HCTZ 150/25 - 300/25mg; Irbesartan/HCTZ 150/25 – 300/25 mg; Amlodipine/HCTZ 5/25 – 10/25mg; |
Change in msDBP from baseline (start of double-blind treatment) to wk 8 endpoint (aliskiren/HCTZ 300/25 mg vs placebo–HCTZ25 mg) | 100% |
| Nickenig (2008) [20] | Randomized, double-blind, multicenter; 8 wks; clinic; trough BP; n=880 | Age ≥ 18 yrs. Eligibility for single-blind phase: msDBP ≥95 and <110 mmHg or msDBP ≥85 and <110 mmHg if treated for HT within the 4 wks prior to screening (baseline). Eligibility for double-blind phase: msDBP ≥90 and <110 mmHg after 4 wks of aliskiren 300 mg monotherapy. Mean age 55 yrs;55% men;83% Caucasian. | Single-blind treatment (4 wks): Aliskiren 300mg. Double-blind treatment (8 wks): Aliskiren 300mg; Aliskiren/HCTZ 300/12.5, 300/25mg. |
Change in msDBP from baseline (start of double-blind treatment) to wk 8 endpoint (aliskiren monotherapy vs combination therapy) | 100% |
| Blumenstein (2009) [23] | Randomized, double-blind, multicenter; 8 wks; clinic; trough BP; n=722 | Age ≥ 18 yrs. Eligibility for single-blind phase: patients with HT, who were newly diagnosed, untreated or treated at the time of screening. Newly diagnosed pts or pts who had not been treated for HT in the 4 wks prior to screening had to have msDBP ≥95 and <110 mmHg at the time of the screening. Eligibility for double-blind phase: msDBP ≥90 and <110 mmHg after 4 wks of HCTZ 25 mg monotherapy. Mean age 54 yrs; 59% men;91% Caucasian. | Single-blind treatment (4 wks): HCTZ 25mg. Double-blind treatment (8 wks): HCTZ 25mg; Aliskiren/HCTZ 150/25,300/25mg. |
Change in msDBP from baseline (start of double-blind treatment) to wk 8 endpoint (HCTZ monotherapy vs combination therapy) | 100% |
| Geiger (2009) [24] | Randomized, double-blind, multicenter; 8 wks; clinic; trough BP; n=641 | Age≥ 18 yrs. Eligibility for single-blind phase: pts with mild to moderate HT taking antihypertensive agents. Eligibility for double-blind phase: msDBP ≥95 and <110 mmHg after 4 wks of HCTZ monotherapy. Mean age 53 yrs; 57% men; 86% Caucasian. |
Single-blind treatment (4 wks): HCTZ 12.5mg for 1 wk followed by HCTZ 25mg for 3 wks. Double-blind treatment (8 wks): HCTZ 25mg; Aliskiren/HCTZ 150/25mg for 4 wks followed by 300/25mg for another 4 wks; Valsartan/HCTZ 160/25mg for 4 wks followed by 320/25mg for another 4 wks; Aliskiren/Valsartan/HCTZ 150/160/25mg for 4 wks followed by 300/320/25mg for another 4 wks. |
Change in msDBP from baseline (start of double-blind treatment) to wk 8 endpoint (aliskiren/HCTZ and valsartan/HCTZ vs aliskiren/valsartan/HCTZ) | 60%d |