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Completed

NCT Number: NCT01281306

An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

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Key information

Conditions

Systolic Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Isolated Systolic Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
  • Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Exclusion criteria

  • Severe hypertension
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
  • History or evidence of a secondary form of hypertension.
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

LCZ696

Drug

LCZ696 was supplied as tablets in blister cards in 100 mg strengths.

valsartan

Drug

Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.

AHU377

Drug

AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.

Placebo

Drug

Placebo was supplied as tablets in blister cards.

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in Mean Diastolic Blood Pressure (msDBP)

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

  2. Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)

    Time frame: Baseline, 8 weeks

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

  3. Change From Baseline in Daytime maSBP and maDBP

    Time frame: Baseline, 8 weeks

    Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

  4. Change From Baseline in Nighttime maSBP and maDBP

    Time frame: Baseline and 8 weeks

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

  5. Change From Baseline in Mean Sitting Pulse Pressure

    Time frame: Baseline, 8 weeks

    Pulse rate measurements were performed. A negative change from baseline indicates improvement.

  6. Change From Baseline in Mean Ambulatory Pulse Pressure

    Time frame: Baseline, 8 weeks

    Pulse rate measurements were performed. A negative change from baseline indicates improvement.

  7. Change From Baseline in maSBP and maDBP in Dippers

    Time frame: Baseline, 8 weeks

    Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.

  8. Change From Baseline in maSBP and maDBP in Non-dippers

    Time frame: Baseline, 8 weeks

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.

  9. Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

  10. Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

  11. Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age

    Time frame: Baseline, 8 weeks

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

  12. Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age

    Time frame: Baseline, 8 weeks

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

  13. Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response

    Time frame: 8 weeks

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline.

  14. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Time frame: 8 weeks

    Adverse event monitoring was conducted throughout the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2011
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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