Clinical trial NCT00705575: Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension
Official title: A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Essential Hypertension
Stage II
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 688
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 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.

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)
timeFrame: Baseline to end of study (Week 12)
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
timeFrame: Baseline to Week 12
measure: 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
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Investigative Site
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Investigative Site
city: Quito
country: Ecuador
facility: Investigative Site
city: Berlin
country: Germany
facility: Investigative Site
city: Guatemala City
country: Guatemala
facility: Investigative Site
city: Rome
country: Italy
facility: Investigative Site
city: Basel
country: Switzerland
facility: Investigative Site
city: Ankara
country: Turkey
facility: Investigative Site
Study officials:
References: