Phase 3
N=688
Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00705575 ↗Enrolled (actual)
688
Serious AEs
0.9%
Results posted
Jan 2011
Primary outcome: Primary: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12) — -30.01; -20.29 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) (Drug); Aliskiren (300 mg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12) |
-30.01; -20.29 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8 |
-30.09; -20.75 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12 |
-13.69; -7.99; -12.64; -8.18 | — |
| SECONDARY Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12 |
53.5; 30.4; 54.6; 32.2 | — |
Summary
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.
Eligibility Criteria
Inclusion Criteria
- Outpatients ≥18 years of age.
- Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.
Exclusion Criteria
- Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (msDBP) ≥ 110 mmHg.
- Secondary form of hypertension.
- Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV).
- Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
- Second or third degree heart block without a pacemaker.
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1.
- Clinically significant valvular heart disease.
- Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
- Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
- Inability to discontinue prior antihypertensive or other CV medications as required by the protocol.
- Patients with Type 1 diabetes mellitus.
- Patients with Type 2 diabetes mellitus not well controlled .
- Elevated Serum potassium (over 5.3 mEq/L (mmol/L).
- Any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00705575). 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.