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CompletedNCT00809926VANTAGEUpdated May 2, 2011Results posted

8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 Hypertension

A Phase 4 interventional study of Valsartan/aliskiren and Valsartan in Stage 2 Hypertension, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-02.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
451
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.

02

Conditions studied

  • Stage 2 Hypertension

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Keywords

  • Hypertension, aliskiren and valsartan
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 451 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
  • Men or women 18 years and older.
  • Patients with Stage 2 systolic hypertension; defined as having a MSSBP ≥160 mmHg and \<180 mmHg at Visit 5 (randomization).

Exclusion criteria

Exclusion Criteria:

  • Use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of Visit 1.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
  • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
  • Severe hypertension (an office cuff MSDBP ≥110 mmHg and/or MSSBP ≥180 mmHg).
  • Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg).
  • Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
  • History or evidence of a secondary form of hypertension.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
451 participants (actual)

Study arms

  • Experimental
    Valsartan/aliskiren

    Drug: Valsartan/aliskiren

  • Active comparator
    Valsartan

    Drug: Valsartan

Interventions

  • DrugValsartan/aliskiren

    Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks

  • DrugValsartan

    Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

    To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

    Time frame: Baseline to Week 8

Secondary outcomes

  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

    To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.

    Time frame: Baseline to Week 8

  2. Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8

    To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP \<140 mmHg and MSDBP \<90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

    Time frame: At Week 8

  3. Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8

    To compare the percentage of responders (defined as patients with MSSBP \<140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

    Time frame: At Week 8

  4. Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8

    To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

    Time frame: Baseline to Week 8

  5. Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8

    To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

    Time frame: Baseline to Week 8

Other outcomes

  1. Completers Analysis for Change From Baseline in MSSBP at Week 8

    To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population - patients who completed the double-blind treatment period.

    Time frame: Baseline to week 8

  2. Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8

    To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)

    Time frame: Baseline through week 8

  3. Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).

    To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.

    Time frame: Baseline to week 8

  4. Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)

    To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.

    Time frame: Baseline to week 8

07

Results

Posted May 2, 2011

Participant flow

Participant flow — Overall Study
MilestoneValsartan/AliskirenValsartan
Started232219
Completed201196
Not completed3123
Withdrew: Adverse event1810
Withdrew: Unsatisfactory therapeutic effect33
Withdrew: Patient withdrew consent86
Withdrew: Lost to follow-up21
Withdrew: Administrative problems01
Withdrew: Protocol deviation02

Outcome measures

PrimaryChange From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

Time frame:
Baseline to Week 8
Reported as:
Mean · mm Hg
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
mm HgValsartan/AliskirenValsartan
Baseline164.8 ± 4.54166.2 ± 5.23
Week 8142.3 ± 17.01145.6 ± 17.55
Change from Baseline to Week 8-22.5 ± 16.04-20.6 ± 16.25
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · ANCOVA · p = 0.295 · Least square mean difference: -1.6 · 95% CI -4.61 to 1.40
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.

Time frame:
Baseline to Week 8
Reported as:
Mean · mm Hg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
mm HgValsartan/AliskirenValsartan
Baseline93.9 ± 8.2294.8 ± 8.68
Week 885.7 ± 10.9486.4 ± 10.34
Change from Baseline to Week 8-8.2 ± 9.77-8.3 ± 9.49
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · ANCOVA · p = 0.790 · Least square mean difference: -0.2 · 95% CI -1.93 to 1.47
SecondaryPercentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8

To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP \<140 mmHg and MSDBP \<90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

Time frame:
At Week 8
Reported as:
Number · percentage of patients
Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8
percentage of patientsValsartan/AliskirenValsartan
Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 844.336.2
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · Cochran-Mantel-Haenszel · p = 0.101 · Difference: 8.1 · 95% CI -1.56 to 17.67
SecondaryPercentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8

To compare the percentage of responders (defined as patients with MSSBP \<140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

Time frame:
At Week 8
Reported as:
Number · percentage of responders
Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8
percentage of respondersValsartan/AliskirenValsartan
Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 864.753.1
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · Cochran-Mantel-Haenszel · p = 0.018 · Difference: 11.6 · 95% CI 2.00 to 21.33
SecondaryMean Change From Baseline in Plasma Renin Activity (PRA) at Week 8

To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

Time frame:
Baseline to Week 8
Reported as:
Mean · ng/mL/h
Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8
ng/mL/hValsartan/AliskirenValsartan
Baseline0.992 ± 1.2900.831 ± 0.854
Week 80.436 ± 0.6592.450 ± 3.73
Change from Baseline to Week 8-0.540 ± 1.2851.577 ± 3.528
SecondaryMean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8

To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.

Time frame:
Baseline to Week 8
Reported as:
Mean · ng/L
Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
ng/LValsartan/AliskirenValsartan
Baseline8.286 ± 10.8938.065 ± 14.932
Week 8142.833 ± 293.22820.089 ± 31.771
Change from Baseline to Week 8135.515 ± 296.75811.988 ± 32.679
Other pre-specifiedCompleters Analysis for Change From Baseline in MSSBP at Week 8

To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population - patients who completed the double-blind treatment period.

Time frame:
Baseline to week 8
Reported as:
Mean · mm Hg
Completers Analysis for Change From Baseline in MSSBP at Week 8
mm HgValsartan/AliskirenValsartan
Baseline164.8 ± 4.54166.2 ± 5.23
Week 8140.9 ± 15.74145.9 ± 16.89
Change from Baseline to Week 8-24.0 ± 14.70-20.3 ± 15.49
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · ANCOVA · p = 0.028 · Least square mean difference: -3.4 · 95% CI -6.34 to -0.37
Other pre-specifiedLongitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8

To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)

Time frame:
Baseline through week 8
Reported as:
Least squares mean · mm Hg
Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8
mm HgValsartan/AliskirenValsartan
Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8-23.2 ± 1.04-20.1 ± 1.08
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · GENMOD · p = 0.040 · Least square mean difference: -3.1 · 95% CI -6.02 to -0.14Based on a generalized estimating equations using SAS procedure GENMOD.
Other pre-specifiedChange From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).

To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.

Time frame:
Baseline to week 8
Reported as:
Mean · mm Hg
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).
mm HgValsartan/AliskirenValsartan
Baseline146.1 ± 9.14143.5 ± 14.10
Week 8130.3 ± 13.41137.6 ± 17.11
Change from Baseline to Week 8-15.8 ± 11.42-6.0 ± 13.34
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · ANCOVA · p = 0.004 · Least square mean difference: -8.7 · 95% CI -14.38 to -2.93
Other pre-specifiedChange From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)

To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.

Time frame:
Baseline to week 8
Reported as:
Mean · mm Hg
Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)
mm HgValsartan/AliskirenValsartan
Baseline87.9 ± 7.2885.7 ± 9.26
Week 878.2 ± 9.4481.7 ± 10.11
Change from Baseline to Week 8-9.7 ± 7.02-4.0 ± 8.09
Statistical analysis
  • Valsartan/Aliskiren vs Valsartan · ANCOVA · p = 0.006 · Least square mean difference: -4.9 · 95% CI -8.37 to -1.42

Adverse events

Collected over Baseline through week 8. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Valsartan/ Aliskiren—5/232 (2.2%)14/232 (6%)
Valsartan—3/219 (1.4%)15/219 (6.8%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventValsartan/ AliskirenValsartan
Non-cardiac chest painGeneral disorders2/2320/219
DehydrationMetabolism and nutrition disorders2/2320/219
HypoglycaemiaMetabolism and nutrition disorders0/2321/219
AnaesthesiaNervous system disorders0/2321/219
HemiparesisNervous system disorders0/2321/219
AnxietyPsychiatric disorders0/2321/219
Confusional statePsychiatric disorders0/2321/219
Conversion disorderPsychiatric disorders0/2321/219
Deep vein thrombosisVascular disorders0/2321/219
LymphocytosisBlood and lymphatic system disorders1/2320/219
Most frequent other events
Most frequent other events
EventValsartan/ AliskirenValsartan
HeadacheNervous system disorders14/23215/219

Baseline characteristics

Age Continuous
Age Continuous(years)Valsartan/AliskirenValsartanTotal
Mean57.5 ± 11.156.7 ± 11.057.1 ± 11.0
Sex: Female, Male
Sex: Female, Male(Participants)Valsartan/AliskirenValsartanTotal
Female107116223
Male125103228
08

Study locations

1 site
  • Sites in USA
    East Hanover, New Jersey 07936, United States
09

References and documents

Publications

  • Flack JM, Yadao AM, Purkayastha D, Samuel R, White WB. Comparison of the effects of aliskiren/valsartan in combination versus valsartan alone in patients with stage 2 hypertension. J Am Soc Hypertens. 2012 Mar-Apr;6(2):142-51. doi: 10.1016/j.jash.2011.11.004. Epub 2012 Feb 9. PubMed 22321963 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00809926
Lead sponsor
Novartis
First posted
Dec 17, 2008
Start date
Jan 2009
Primary completion
Jul 2009
Completion
Jul 2009
Results posted
May 2, 2011
Last update
May 2, 2011

Study contacts

Novartis
study chair · Novartis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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