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

NCT00809926 | Completed Phase 4 Results

• 1 other identifier: CSPV100AUS01
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stage 2 Hypertension

Keywords

Hypertension, aliskiren and valsartan

Outcome Measures

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.

  Baseline to Week 8

Secondary Outcomes (5)

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

  Baseline to Week 8

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

  At Week 8

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

  At Week 8

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

  Baseline to Week 8

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

  Baseline to Week 8

Other Outcomes (4)

• Completers Analysis for Change From Baseline in MSSBP at Week 8

  Baseline to week 8

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

  Baseline through week 8

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

  Baseline to week 8

Study Arms (2)

Valsartan/aliskiren

EXPERIMENTAL

Drug: Valsartan/aliskiren

Valsartan

ACTIVE COMPARATOR

Drug: Valsartan

Interventions

Valsartan/aliskiren DRUG

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

Valsartan/aliskiren

Valsartan DRUG

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

Valsartan

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Sites in USA

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• 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.

  PMID: 22321963 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; aliskiren

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

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, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 2, 2011
• Results First Posted: May 2, 2011

Record last verified: 2011-03

Locations

US (1)