A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

NCT00386607 | Completed Phase 3 Results

• 2 other identifiers: CSPV100A2301CSPV100A2301E1
• Study Type: interventional
• Target: 601
• Locations: 4 countries
• Sites: 4

Brief Summary

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Conditions

Hypertension

Keywords

Hypertension, aliskiren, valsartan, HCTZ, blood pressure

Outcome Measures

Primary Outcomes (2)

• Overall Percentage of Patients With Adverse Events

  Month 12

• Overall Percentage of Patients With Adverse Events

  adverse event data obtained from both the core study and the 6 month extension study.

  Month 18

Secondary Outcomes (6)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure.

  Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54

• Change From Baseline in Mean Sitting Systolic Blood Pressure.

  Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54

• Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg

  .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54

• Change From Baseline in Mean Sitting Diastolic Blood Pressure

  Baseline and Month 18

• Change From Baseline in Mean Sitting Systolic Blood Pressure

  Baseline and Month 18

Study Arms (2)

Core Treatment

EXPERIMENTAL

Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.

Drug: Aliskiren; Drug: Valsartan

Extension Treatment

EXPERIMENTAL

For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg. The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.

Drug: Aliskiren; Drug: Valsartan; Drug: Hydrochlorothiazide (HCTZ)

Interventions

Aliskiren DRUG

Aliskiren 300 mg

Core Treatment; Extension Treatment

Valsartan DRUG

Valsartan 320 mg

Core Treatment; Extension Treatment

Hydrochlorothiazide (HCTZ) DRUG

Hydrochlorothiazide (HCTZ) 12.5-25 mg

Extension Treatment

Eligibility Criteria

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

You may qualify if:

• Male and female outpatients 18 years of age and older.
• For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
• For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)
• Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).

You may not qualify if:

• Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
• Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
• History or evidence of a secondary form of hypertension.
• History of hypertensive encephalopathy or cerebrovascular accident.

Sponsors & Collaborators

• Novartis: lead

Study Sites (4)

Investigative Centers

San Diego, California, United States

Location

Investigative Centers

Canada, Canada

Location

Investigative Centers

Germany, Germany

Location

Investigative Centers

Netherlands, Netherlands

Location

Related Publications (1)

• Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9.

  PMID: 21062137 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Valsartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Open label study with no comparator treatment/arm.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 10, 2014
• Results First Posted: May 10, 2011

Record last verified: 2014-01

Locations

CA (1); DE (1); NL (1); US (1)