Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Essential Hypertension Stage II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

Group Type EXPERIMENTAL

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

Intervention Type DRUG

During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.

Aliskiren (300 mg)

Group Type ACTIVE_COMPARATOR

Aliskiren (300 mg)

Intervention Type DRUG

During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Interventions

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Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.

Intervention Type DRUG

Aliskiren (300 mg)

During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Novartis

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CSPP100A2353

Identifier Type: -

Identifier Source: org_study_id

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

Aliskiren (300 mg)

Aliskiren (300 mg)

Interventions

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

Aliskiren (300 mg)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novartis

Responsible Party

Locations

Investigative Site

Investigative Site

Investigative Site

Investigative Site

Investigative Site

Investigative Site

Investigative Site

Investigative Site

Countries

Other Identifiers

CSPP100A2353