Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765674
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE October 2, 2008
First Posted Date  ICMJE October 3, 2008
Results First Submitted Date  ICMJE January 12, 2011
Results First Posted Date  ICMJE May 9, 2011
Last Update Posted Date May 9, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]
Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
Vital signs at every visit [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00765674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]
    Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
  • Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ]
    Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.
  • Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ]
    Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
  • Vital signs at every visit [ Time Frame: 8 weeks ]
  • Adverse events at every visit [ Time Frame: 8 weeks ]
  • 24-hour ambulatory blood pressure measurement of a subset of patients at Day 1 and Day 56 (end of study) [ Time Frame: 8 weeks ]
  • Changes in biomarker assessments (PRA, PRC) at Day 1 and Day 56 in subset of patients [ Time Frame: 8 weeks ]
  • Pharmacokinetics [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
Official Title  ICMJE An 8 Week, Double-blind, Randomized, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate to Severe Hypertension
Brief Summary This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Aliskiren
    150 and 300 mg tablets
  • Drug: Amlodipine
    5 and 10 mg capsules
  • Drug: Hydrochlorothiazide (HCTZ)
    12.5 and 25 mg capsules
  • Drug: Placebo
    tablet
  • Drug: Placebo
    capsules
Study Arms  ICMJE
  • Experimental: Aliskiren / amlodipine
    Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
    Interventions:
    • Drug: Aliskiren
    • Drug: Amlodipine
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: Aliskiren / hydrochlorothiazide
    Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
    Interventions:
    • Drug: Aliskiren
    • Drug: Hydrochlorothiazide (HCTZ)
    • Drug: Placebo
    • Drug: Placebo
  • Experimental: Amlodipine / hydrochlorothiazide
    Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
    Interventions:
    • Drug: Amlodipine
    • Drug: Hydrochlorothiazide (HCTZ)
    • Drug: Placebo
  • Experimental: Aliskiren / amlodipine / hydrochlorothiazide
    Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
    Interventions:
    • Drug: Aliskiren
    • Drug: Amlodipine
    • Drug: Hydrochlorothiazide (HCTZ)
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2011)
1191
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2008)
1160
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female
  • 18 years of age or older
  • msDBP and msSBP requirements:

    • 3A:

      • Diagnosis of moderate to severe hypertension (msSBP ≥ 160 mmHg and < 200 mmHg, and/or msDBP ≥ 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)
      • In addition, at the visit immediately prior to the above qualifying visit, patients were also to have msSBP ≥ 145 mmHg and < 200 mmHg and msDBP ≥ 95 mmHg and < 120 mmHg) at Visits 3, 5 or 5.
      • Patients had to meet the above two sets of requirements at subsequent adjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6.
    • OR
    • 3B:

      • msSBP ≥ 180 mmHg and < 200 mmHg with msDBP ≥ 95 mmHg and < 120 mmHg, or msDBP ≥ 110 mmHg and < 120 mmHg with msSBP ≥ 150 mmHg and < 200 mmHg after at least one week of treatment with placebo (Visit 3 and on).

Exclusion Criteria:

  • Continued use of anti-hypertensive medicines or use of 4 or more hypertensive medicines at study start
  • Patients with an msSBP ≥ 200 mmHg or msDBP ≥ 120 mmHg at any time during the placebo run-in period were to be discontinued from the study.
  • Extremely elevated (defined) blood pressure at any point during the study
  • Pregnant or lactating women
  • Pre-menopausal women not taking accepted form of birth control
  • History or evidence of secondary form of hypertension
  • History of cardiovascular conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Germany,   Israel,   Italy,   Latvia,   Lithuania,   Romania,   Sweden,   Turkey,   United States
Removed Location Countries South Africa
 
Administrative Information
NCT Number  ICMJE NCT00765674
Other Study ID Numbers  ICMJE CSAH100A2302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP