Phase 4
N=412
Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00942994 ↗Enrolled (actual)
412
Serious AEs
0.7%
Results posted
Apr 2011
Primary outcome: Primary: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 — 167.08; 167.41; 130.73; 137.87 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren/Amlodipine (Drug); Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 |
167.08; 167.41; 130.73; 137.87; -36.43; -29.54 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 |
95.25; 95.25; 80.10; 83.17; -15.10; -12.08 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks |
50.5; 40.2; 74.8; 57.4; 81.7; 67.9 | — |
| SECONDARY Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks. |
79.2; 72.2; 91.1; 84.7; 92.6; 91.9 | — |
Summary
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
Eligibility Criteria
Inclusion Criteria
- Patients who are newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Men or women 18 years and older of minority background; self-identified.
- Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and 180 mmHg) taking more than 1 antihypertensive medication at Visit 1.
Data sourced from ClinicalTrials.gov (NCT00942994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.