Clinical trial NCT00654875: Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.
Official title: A 10 Week, Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg qd) to Twice Daily Dosing of Aliskiren (150 mg Bid) in Patients With Essential Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension


Eligibility criteria: Inclusion Criteria:

* Have diagnosis of uncomplicated essential hypertension; newly diagnosed or who have not received antihypertension medication within 4 weeks of visit 1 must have an office cuff mean sitting Diastolic Blood pressure (msDBP) \> 100 mmHg and \< 110 mmHg at visit 1. If patient is receiving antihypertensive treatment, must have a cuff msDBP \> 95 mmHg and \< 110 mmHg at visit 1
* Prior to randomization, all patients must have an office cuff msDBP \>or= 100 mmHg and \<or = 110 mmHg.

Exclusion Criteria:

* Participation in another aliskiren trial or previous treatment with aliskiren during last 6 months and who qualified to be randomized or enrolled into the active drug treatment period
* Pregnant or nursing women
* Women of child bearing potential unwilling to use protocol specific contraceptive methods
* Office cuff blood pressure of msDBP ≥ 112 mmHg and/or mean sitting Systolic Blood Pressure (msSBP) ≥ 200 mmHg).
* Secondary form of hypertension
* History of heart failure New York Heart Association (NYHA Class II, III and IV)
* Previous history of hypertensive encephalopathy or stroke, transient ischemic attack (TIA), heart attack, coronary bypass surgery or any percutaneous coronary intervention (PCI)
* Elevated Serum potassium (\> or = 5.3 mEq/L (mmol/L) at Visit 1
* Type 1 or Type 2 diabetes mellitus not well controlled
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period
timeFrame: Baseline, Week 6
measure: Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period
timeFrame: Baseline, Week 6
measure: Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)
timeFrame: Baseline, Week 6
measure: Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure
timeFrame: Baseline, Week 6
measure: Percentage of Participants Achieving Blood Pressure Control at Week 6
timeFrame: Week 6
measure: Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)
timeFrame: Week 10
Other outcomes:
Locations:
city: Zanesville
country: United States
facility: Investigative Site
state: Ohio
city: Frankfurt
country: Germany
facility: Investigative Site
city: Valencia
country: Spain
facility: Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: