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.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00654875
First received: April 3, 2008
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Essential Hypertension
Drug: Aliskiren
Drug: Placebo to Aliskiren
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 10 Week, Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg qd) to Twice Daily Dosing of Aliskiren (150 mg Bid) in Patients With Essential Hypertension.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.

  • 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 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.

  • Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.

  • Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.

  • Percentage of Participants Achieving Blood Pressure Control at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6).

    Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg.


  • Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10) [ Time Frame: Week 10 ] [ Designated as safety issue: No ]

    After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10).

    Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg.



Enrollment: 328
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren 300 mg (Once a Day)
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
Aliskiren supplied in 150 mg and 300 mg tablets.
Other Name: Tekturna, Rasilez
Drug: Placebo to Aliskiren
Placebo to Aliskiren matching 150 and 300 mg tablets
Experimental: Aliskiren 150 mg (Twice a Day)
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
Aliskiren supplied in 150 mg and 300 mg tablets.
Other Name: Tekturna, Rasilez
Drug: Placebo to Aliskiren
Placebo to Aliskiren matching 150 and 300 mg tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654875

Locations
United States, Ohio
Investigative Site
Zanesville, Ohio, United States
Germany
Investigative Site
Frankfurt, Germany
Spain
Investigative Site
Valencia, Spain
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00654875     History of Changes
Other Study ID Numbers: CSPP100A2403
Study First Received: April 3, 2008
Results First Received: December 13, 2010
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Essential Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014