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

NCT00705575 | Completed Phase 3 Results

• 1 other identifier: CSPP100A2353
• Study Type: interventional
• Target: 688
• Locations: 8 countries
• Sites: 8

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.

Conditions

Hypertension

Keywords

Essential Hypertension; Stage II

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)

  At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.

  Baseline to end of study (Week 12)

Secondary Outcomes (3)

• Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8

  Baseline to Week 8

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12

  Baseline to Week 12

• 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

  Baseline to Week 12

Study Arms (2)

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

EXPERIMENTAL

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

Aliskiren (300 mg)

ACTIVE COMPARATOR

Drug: Aliskiren (300 mg)

Interventions

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

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

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

Aliskiren (300 mg) DRUG

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

Aliskiren (300 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis: lead

Study Sites (8)

Investigative Site

East Hanover, New Jersey, 07936, United States

Location

Investigative Site

Buenos Aires, Argentina

Location

Investigative Site

Quito, Ecuador

Location

Investigative Site

Berlin, Germany

Location

Investigative Site

Guatemala City, Guatemala

Location

Investigative Site

Rome, Italy

Location

Investigative Site

Basel, Switzerland

Location

Investigative Site

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

aliskiren; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 26, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 30, 2011
• Results First Posted: January 21, 2011

Record last verified: 2011-05

Locations

IT (1); DE (1); AR (1); EC (1); GU (1); TU (1); CH (1); US (1)