Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

NCT00931710 | Completed Phase 4 Results

• 1 other identifier: CVEA489AUS01
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Conditions

Stage 2 Systolic Hypertension

Keywords

Hypertension; combination therapy; valsartan; cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Systolic Blood Pressure After 6 Weeks

  To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.

  Baseline to Week 6

Secondary Outcomes (5)

• Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks

  Baseline to Week 6

• Cumulative Percentage of Patients Achieving Blood Pressure Control

  3 and 6 weeks

• Cumulative Percentage of Treatment Responders

  3 and 6 weeks

• Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks

  Baseline to week 12

• Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit

  3, 6, 9 and 12 weeks

Study Arms (2)

Valsartan/amlodipine/HCTZ

EXPERIMENTAL

Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.

Drug: valsartan, amlodipine, HCTZ

Losartan/HCTZ

ACTIVE COMPARATOR

Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.

Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ

Interventions

valsartan, amlodipine, HCTZ DRUG

combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study

Valsartan/amlodipine/HCTZ

Losartan, HCTZ followed by valsartan, amlodipine, HCTZ DRUG

losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study

Losartan/HCTZ

Eligibility Criteria

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

You may qualify if:

• Male or female outpatient of 18 years of age or greater
• Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and \< 200 mmHg at randomization
• Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

You may not qualify if:

• Office systolic blood pressure \>200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
• Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
• Refractory hypertension, defined as blood pressure \>140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
• Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

sites in USA

East Hanover, New Jersey, United States

Location

MeSH Terms

Conditions

Isolated Systolic Hypertension; Hypertension; Cardiovascular Diseases

Interventions

Valsartan; Amlodipine; Hydrochlorothiazide; Losartan

Condition Hierarchy (Ancestors)

Essential Hypertension; Vascular 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; Dihydropyridines; Pyridines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  862-778-8300

  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

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 7, 2011
• Results First Posted: February 4, 2011

Record last verified: 2011-03

Locations

US (1)