Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus

NCT00927394 | Completed Phase 4 Results

• 1 other identifier: CSPV100AUS02
• Study Type: interventional
• Target: 1,143
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.

Conditions

Hypertension

Keywords

Hypertension, Type II Diabetes, Aliskiren, Valsartan,; Systolic blood pressure, Diastolic blood pressure,; Stage II, Combination

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8

  The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.

  baseline, week 8

Secondary Outcomes (11)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

  Baseline, week 8

• Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8

  baseline, week 8

• Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8

  baseline, week 8

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

  Baseline, week 8

• Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8

  baseline, week 8

Study Arms (2)

Combination Therapy: Aliskiren + Valsartan

EXPERIMENTAL

To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks

Drug: Aliskiren; Drug: Valsartan; Drug: Placebo for Aliskiren; Drug: Placebo for Valsartan

Monotherapy: Valsartan

ACTIVE COMPARATOR

To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.

Drug: Valsartan; Drug: Placebo for Aliskiren; Drug: Placebo for Valsartan

Interventions

Aliskiren DRUG

Aliskiren 150 mg tablet

Combination Therapy: Aliskiren + Valsartan

Valsartan DRUG

Valsartan 160 mg capsules

Combination Therapy: Aliskiren + Valsartan; Monotherapy: Valsartan

Placebo for Aliskiren DRUG

Placebo for Aliskiren 150 mg tablets

Combination Therapy: Aliskiren + Valsartan; Monotherapy: Valsartan

Placebo for Valsartan DRUG

Placebo for Valsartan 160 mg capsules

Combination Therapy: Aliskiren + Valsartan; Monotherapy: 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 Type 2 diabetes mellitus with an HbA1c ≤ 9 % at visit 1 and on a stable anti-diabetic regimen not including insulin or stable diet and exercise for at least 4 weeks prior to visit 1.
• Cohort 1:
• Patients with Stage 2 systolic hypertension, defined as having a MSSBP ≥160 mmHg and \<200 mmHg at Visit 5 (randomization).
• Patients who have been newly diagnosed with hypertension or who have not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 1, otherwise, they will be considered screen failures.
• Patients receiving antihypertensive medication must have a MSSBP of ≥150 mmHg and \<200 mmHg at Study Visit 1, otherwise they will be considered screen failures.
• Cohort 2:
• Patients must also have had a mean 8-hour daytime ambulatory systolic blood pressure (ASBP) ≥140 mmHg AND mean 8-hour daytime ambulatory diastolic blood pressure (ADBP) ≥90 mmHg at Visit 5 (randomization).
• Hypertensive patients with MSSBP ≥150 mmHg and but \<200 mmHg AND MSDBP ≥95 but \<120 mmHg at Visit 5 (randomization).
• Patients who had been newly diagnosed with hypertension or who had not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have had MSSBP ≥150 mmHg but \<200 mmHg and MSDBP ≥95 but \<120 mmHg at Visit 1, otherwise, they were considered screen failures.

You may not qualify if:

• Office blood pressure measured by cuff (MSSBP ≥200 mmHg or MSDBP ≥120 mmHg).
• History or evidence of secondary hypertension of any etiology.
• Refractory hypertension, defined as having uncontrolled BP (≥140/90 mmHg) while receiving 3 antihypertensive medications at the maximum approved dose of each drug, one of which must be a diuretic.
• Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
• Type 2 diabetes mellitus currently requiring insulin treatment.
• modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
• Serum sodium less than lower limit of normal, serum potassium \< 3.5 mEq/L or ≥ 5.3 mEq/L at Visit 1.
• Known Keith-Wagener grade III or IV hypertensive retinopathy.
• Cohort 1:
• \- Patients with known diabetic retinopathy (eg, having a history of laser therapy for diabetic retinopathy) or diabetic neuropathy (eg, receiving medication for diabetic neuropathy).
• Cohort 2:
• \- Patients with known diabetic retinopathy or diabetic neuropathy and/or having a history of treatment for either.

Sponsors & Collaborators

• Novartis: lead

Study Sites (4)

Investigative Site

Newark, Delaware, USA, United States

Location

Investigative Site

Kansas City, Missouri, United States

Location

Investigative Site

Camden, New Jersey, United States

Location

Investigative Site

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

• Bakris GL, Oparil S, Purkayastha D, Yadao AM, Alessi T, Sowers JR. Randomized study of antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan monotherapy in hypertensive participants with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2013 Feb;15(2):92-100. doi: 10.1111/jch.12032. Epub 2012 Oct 26.

  PMID: 23339726 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

aliskiren; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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 Directors
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

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, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 6, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-12

Locations

US (4)