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.

• ClinicalTrials.gov Identifier: NCT00654875
• Recruitment Status: Completed
• First Posted: April 9, 2008
• Results First Posted: June 15, 2011
• Last Update Posted: June 28, 2011
• Sponsor: Novartis
• Information provided by: Novartis

Study Description

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

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Drug: Aliskiren; Drug: Placebo to Aliskiren	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 328 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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.
• Study Start Date: March 2008
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) [ Time Frame: Baseline, Week 6 ]
   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 :

1. 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 ]
   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.
2. 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 ]
   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.
3. Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) [ Time Frame: Baseline, Week 6 ]
   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.
4. Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure [ Time Frame: Baseline, Week 6 ]
   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.
5. Percentage of Participants Achieving Blood Pressure Control at Week 6 [ Time Frame: Week 6 ]

   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.

6. Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10) [ Time Frame: Week 10 ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00654875
• Other Study ID Numbers: CSPP100A2403
• First Posted: April 9, 2008
• Results First Posted: June 15, 2011
• Last Update Posted: June 28, 2011
• Last Verified: June 2011

Keywords provided by Novartis:

Essential Hypertension

Additional relevant MeSH terms:

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases