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.

NCT00654875 | Completed Phase 4 Results

• 1 other identifier: CSPP100A2403
• Study Type: interventional
• Target: 328
• Locations: 3 countries
• Sites: 3

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

Conditions

Essential Hypertension

Keywords

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)

  An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.

  Baseline, Week 6

Secondary Outcomes (6)

• 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

  Baseline, Week 6

• 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

  Baseline, Week 6

• Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)

  Baseline, Week 6

• Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure

  Baseline, Week 6

• Percentage of Participants Achieving Blood Pressure Control at Week 6

  Week 6

Study Arms (2)

Aliskiren 300 mg (Once a Day)

EXPERIMENTAL

Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.

Drug: Aliskiren; Drug: Placebo to Aliskiren

Aliskiren 150 mg (Twice a Day)

EXPERIMENTAL

Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.

Drug: Aliskiren; Drug: Placebo to Aliskiren

Interventions

Aliskiren DRUG

Aliskiren supplied in 150 mg and 300 mg tablets.

Also known as: Tekturna, Rasilez

Aliskiren 150 mg (Twice a Day); Aliskiren 300 mg (Once a Day)

Placebo to Aliskiren DRUG

Placebo to Aliskiren matching 150 and 300 mg tablets

Aliskiren 150 mg (Twice a Day); Aliskiren 300 mg (Once a Day)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (3)

Investigative Site

Zanesville, Ohio, United States

Location

Investigative Site

Frankfurt, Germany

Location

Investigative Site

Valencia, Spain

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 28, 2011
• Results First Posted: June 15, 2011

Record last verified: 2011-06

Locations

US (1); DE (1); ES (1)